POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC

Address:510 FURNACE DOCK RD.,CORTLANDT MANOR,NY,10567,US

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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

Automated Occult Blood Analyzer (OOX) (9) Reagent, Occult Blood (KHE) (1)

Premarket Exempt

Clear

OC-Auto - 00816917025711 Catalog Number :

Device Description : Personal Use Kit OC-Auto, Custom Kit for Kaiser Denver

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Light S - 00816917025728 Catalog Number :

Device Description : Personal Use Kit OC-Light S, for Union Hospital

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025735 Catalog Number :

Device Description : OC-Auto SENSOR io Personal Use Kit for Oklahoma University

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025742 Catalog Number :

Device Description : OC-Auto SENSOR io Personal Use Kit for Valley Health

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025759 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for SCL Health - St. Vincent

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025766 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for SCL Health - St. Joseph's

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025773 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for SCL Health - St. Mary's

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025780 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Care Connectors Florida

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025797 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Care Connectors Texas

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00816917025803 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Hawaii Electricians - Clinical Labs of Hawaii

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

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