CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)

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 Xii Deficient Plasma Model Fdp12-10 (1.0ml) And Fdp12-15 (1.5ml).

Pre-market Notification Details

Device IDK981174
510k NumberK981174
Device Name:CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
ClassificationPlasma, Coagulation Factor Deficient
Applicant PRECISION BIOLOGICALS, INC. 900 WINDMILL ROAD UNIT 100 Dartmouth, Nova Scotia,  CA B3b 1p7
ContactSandy Morrison
CorrespondentSandy Morrison
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 Received1998-04-01
Decision Date1999-01-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00843876000374 K981174 000
00843876000367 K981174 000

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