Cryocheck Chromogenic Factor VIII

Test, Qualitative And Quantitative Factor Deficiency

Precision BioLogic

The following data is part of a premarket notification filed by Precision Biologic with the FDA for Cryocheck Chromogenic Factor Viii.

Pre-market Notification Details

Device IDK193204
510k NumberK193204
Device Name:Cryocheck Chromogenic Factor VIII
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant Precision BioLogic 140 Eileen Stubbs Avenue Dartmouth,  CA B3b 0a9
ContactKaren Black
CorrespondentKaren Black
Precision BioLogic 140 Eileen Stubbs Avenue Dartmouth,  CA B3b 0a9
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-20
Decision Date2020-07-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00843876000558 K193204 000
00843876000558 K193204 000
00843876000558 K193204 000
00843876000558 K193204 000
00843876000558 K193204 000
00843876000558 K193204 000
00843876000558 K193204 000
00843876000558 K193204 000
00843876000558 K193204 000
00843876000558 K193204 000
00843876000558 K193204 000
00843876000558 K193204 000

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