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) (5)

Premarket Exempt

Clear

OC-Auto - 00855574005957 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Dartmouth Hitchcock

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005964 Catalog Number :

Device Description : Personal Use Kit OC-Auto, for Denver Hlth Med Ctr

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005971 Catalog Number :

Device Description : Personal Use Kit OC-Auto, Custom Kit for Detroit Receiving Hosp

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005988 Catalog Number :

Device Description : Personal Use Kit OC-Auto, Custom Kit for Sutter East Bay

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

OC-Auto - 00855574005995 Catalog Number :

Device Description : Personal Use Kit OC-Auto, Custom Kit for Westmoreland Hosp

Device Class : 2

Duns Number: 078413594

Premarket Exempt : No

Product Code : OOX

Prescription Use : No

Device Count : 1

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