ASTORIA-PACIFIC, INC.

Address:15130 S.E. 82ND DR.,Clackamas,OR,97015,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

Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use (JJC) (10)

Premarket Exempt

No Yes

Clear

SPOTCHECK - 00725609000304 Catalog Number : 303-A002-03

Device Description : 303A, 2 Heat Bath Cartridge Module

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000311 Catalog Number : 303-A003-03

Device Description : 303A, 3 Heat Bath Cartridge Module

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000328 Catalog Number : 303-A004-03

Device Description : 303A, 4 Heat Bath Cartridge Module

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000335 Catalog Number : 315-A995-00

Device Description : Biotinidase Cartridge

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000342 Catalog Number : 307-A990-00

Device Description : G6PD Cartridge

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000359 Catalog Number : 307-A950-00

Device Description : Total Galactose Cartridge

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000366 Catalog Number : 307-A950-04

Device Description : Total Galactose + GALT Cartridge

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000373 Catalog Number : 307-A980-00A

Device Description : Uridyltransferase Active Cartridge

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000380 Catalog Number : 307-A980-00B

Device Description : Uridyltransferase Blank Cartridge

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000397 Catalog Number : 315-A110-VS2

Device Description : 315-2 Detector, 110 Volt with Tungsten

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

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