CRYO CHECK FACTOR IX DEFICIENT PLASMA

Plasma, Coagulation Factor Deficient

PRECISION BIOLOGICALS, INC.

The following data is part of a premarket notification filed by Precision Biologicals, Inc. with the FDA for Cryo Check Factor Ix Deficient Plasma.

Pre-market Notification Details

Device IDK971226
510k NumberK971226
Device Name:CRYO CHECK FACTOR IX DEFICIENT PLASMA
ClassificationPlasma, Coagulation Factor Deficient
Applicant PRECISION BIOLOGICALS, INC. 900 WINDMILL ROAD UNIT 100 Dartmouth, Nova Scotia,  CA B3b 1p7
ContactStephen L Duff
CorrespondentStephen L Duff
PRECISION BIOLOGICALS, INC. 900 WINDMILL ROAD UNIT 100 Dartmouth, Nova Scotia,  CA B3b 1p7
Product CodeGJT  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-02
Decision Date1997-07-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00843876000312 K971226 000
00843876000305 K971226 000

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