Medical Device Manufacturer · CA , Dartmouth, N.S.

Precision Biologic

10 submissions · 10 cleared · Since 1999
10
Total
10
Cleared
0
Denied

Precision Biologic — FDA 510(k) Submissions

Precision Biologic has submitted 10 FDA 510(k) premarket notifications since 1999, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagent, Russel Viper Venom, Test, Qualitative And Quantitative Factor Deficiency, Plasma, Coagulation Factor Deficient, Plasma, Control, Normal, Antithrombin Iii Quantitation . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
Cryocheck Hex LA
K193556 · GFO Activated Partial... · Hematology
Oct 2020 305d
Cryocheck Chromogenic Factor VIII
K193204 · GGP Test, Qualitative And... · Hematology
Jul 2020 240d
CRYOCHECK WEAK LUPUS POSITIVE CONTROL
K032804 · GGC Control, Plasma, Abnormal · Hematology
Nov 2003 55d
CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50
K023991 · JBQ Antithrombin Iii... · Hematology
Apr 2003 146d
CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50
K023990 · GGP Test, Qualitative And... · Hematology
Mar 2003 106d
REFERENCE CHECK, CATALOG NUMBER-RCN-10
K013708 · GIZ Plasma, Control, Normal · Hematology
Dec 2001 32d
CRYOCHECK LA SURE, MODEL SUR25-10
K990580 · GIR Reagent, Russel Viper Venom · Hematology
Jul 1999 155d
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
K990579 · GIR Reagent, Russel Viper Venom · Hematology
Jul 1999 150d
CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
K990814 · GJT Plasma, Coagulation... · Hematology
Jun 1999 88d
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
K990296 · GJT Plasma, Coagulation... · Hematology
Mar 1999 49d
Filters
All10 Hematology 10