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

Precision Biologic - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1999

Total

Cleared

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) cleared devices by Precision Biologic

10 devices

1-10 of 10

Cryocheck Chromogenic Factor VIII

K193204 · GGP

Hematology · 240d

Cleared Nov 03, 2003

CRYOCHECK WEAK LUPUS POSITIVE CONTROL

K032804 · GGC

Hematology · 55d

Cleared Apr 28, 2003

CHROMOCHECK ANTITHROMBIN 25

K023991 · JBQ

Hematology · 146d

Cleared Mar 19, 2003

CHROMOCHECK PROTEIN C 25

K023990 · GGP

Hematology · 106d

Cleared Dec 10, 2001

REFERENCE CHECK, CATALOG NUMBER-RCN-10

K013708 · GIZ

Hematology · 32d

Cleared Jul 28, 1999

CRYOCHECK LA SURE, MODEL SUR25-10

K990580 · GIR

Hematology · 155d

Cleared Jul 23, 1999

CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)

K990579 · GIR

Hematology · 150d

Cleared Jun 07, 1999

CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15

K990814 · GJT

Hematology · 88d

Cleared Mar 18, 1999

CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML),...

K990296 · GJT

Hematology · 49d

Precision Biologic - FDA 510(k) Cleared Devices

FDA 510(k) cleared devices by Precision Biologic

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