Precision Biologic

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251440CRYOcheck Chromogenic Factor VIIIAugust 25, 2025
K222831CRYOcheck Factor VIII Deficient Plasma with VWFSeptember 13, 2023
K214002CRYOcheck Chromogenic Factor IXDecember 23, 2022
K193556Cryocheck Hex LAOctober 23, 2020
K193204Cryocheck Chromogenic Factor VIIIJuly 17, 2020
K183440CRYOcheck FVIII Inhibitor KitMarch 12, 2019
K060284CRYOCHECK CLOT APCRMay 10, 2006
K043571CRYOCHECK CLOT SMarch 18, 2005
K040987CRYOCHECK CLOT CJune 18, 2004
K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLNovember 3, 2003
K023991CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50April 28, 2003
K023990CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50March 19, 2003
K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10December 10, 2001
K990580CRYOCHECK LA SURE, MODEL SUR25-10July 28, 1999
K990579CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)July 23, 1999
K990814CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15June 7, 1999
K990296CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)March 18, 1999