Precision Biologic is one of 208 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.
Precision Biologic - FDA 510(k) Cleared Devices
Recent clearances: Cryocheck Hex LA, Cryocheck Chromogenic Factor VIII
10
Total
10
Cleared
0
Denied
Precision Biologic has 10 FDA 510(k) cleared hematology devices. Based in Dartmouth, N.S., CA.
Historical record: 10 cleared submissions from 1999 to 2020.
Browse the complete list of FDA 510(k) cleared hematology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Precision Biologic
10 devices
Cleared
Oct 23, 2020
Cryocheck Hex LA
Hematology
305d
Cleared
Jul 17, 2020
Cryocheck Chromogenic Factor VIII
Hematology
240d
Cleared
Nov 03, 2003
CRYOCHECK WEAK LUPUS POSITIVE CONTROL
Hematology
55d
Cleared
Apr 28, 2003
CHROMOCHECK ANTITHROMBIN 25
Hematology
146d
Cleared
Mar 19, 2003
CHROMOCHECK PROTEIN C 25
Hematology
106d
Cleared
Dec 10, 2001
REFERENCE CHECK, CATALOG NUMBER-RCN-10
Hematology
32d
Cleared
Jul 28, 1999
CRYOCHECK LA SURE, MODEL SUR25-10
Hematology
155d
Cleared
Jul 23, 1999
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
Hematology
150d
Cleared
Jun 07, 1999
CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
Hematology
88d
Cleared
Mar 18, 1999
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML),...
Hematology
49d