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FDA 510(k) Applications Submitted by PRECISION BIOLOGIC INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K222831
09/19/2022
CRYOcheck Factor VIII Deficient Plasma with VWF
Precision BioLogic Inc.
K214002
12/21/2021
CRYOcheck Chromogenic Factor IX
Precision BioLogic Inc.
K183440
12/12/2018
CRYOcheck FVIII Inhibitor Kit
Precision BioLogic Inc.
K060284
02/03/2006
CRYOCHECK CLOT APCR
PRECISION BIOLOGIC INC.
K040987
04/15/2004
CRYOCHECK CLOT C
PRECISION BIOLOGIC INC.
K043571
12/27/2004
CRYOCHECK CLOT S
PRECISION BIOLOGIC INC.
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