ACON LABORATORIES, INC.

Address:5850 Oberlin Drive, # 340,SAN DIEGO,CA,92121,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) (JIR) (7) METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) (JIL) (7) DYE-INDICATOR, PH (URINARY, NON-QUANT.) (CEN) (6) NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) (JIN) (3) TEST, URINE LEUKOCYTE (LJX) (2) DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) (JMT) (2) BLOOD, OCCULT, COLORIMETRIC, IN URINE (JIO) (2) REFRACTOMETER FOR CLINICAL USE (JRE) (2) ENZYMATIC METHOD, CREATININE (JFY) (1)

Premarket Exempt

No Yes

Clear

Mission Urinalysis Reagent Strips - 00682607000432 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (SG/PH)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JRE, CEN

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000449 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (ALB/CRE)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIR, JFY

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000456 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (GLU/PH/PRO)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIL, CEN, JIR

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000463 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (GLU/KET/PRO)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIN, JIR, JIL

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000470 Catalog Number :

Device Description : Mission Urinalysis Reagent Strips (GLU/KET/PH)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIL, CEN, JIN

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000487 Catalog Number :

Device Description : Mission Urinalysis Reagent Strip (BLO/NIT/LEU)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIO, LJX, JMT

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000494 Catalog Number :

Device Description : Mission Urinalysis Reagent Strip (GLU/PRO/NIT/LEU)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIR, JIL, LJX, JMT

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000500 Catalog Number :

Device Description : Mission Urinalysis Reagent Strip (GLU/SG/PH/PRO)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIL, CEN, JIR, JRE

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000517 Catalog Number :

Device Description : Mission Urinalysis Reagent Strip (GLU/PRO/PH/BLO)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : CEN, JIO, JIR, JIL

Prescription Use : Yes

Device Count : 100

Mission Urinalysis Reagent Strips - 00682607000524 Catalog Number :

Device Description : Mission Urinalysis Reagent Strip (GLU/KET/PRO/PH)

Device Class :

Duns Number: 781100966

Premarket Exempt : No

Product Code : JIR, JIL, JIN, CEN

Prescription Use : Yes

Device Count : 100

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