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

Precision Biologic, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2004

Recent clearances: CRYOcheck Chromogenic Factor VIII, CRYOcheck Factor VIII Deficient Plasma with VWF, CRYOcheck Chromogenic Factor IX

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Precision Biologic, Inc. Hematology ✕

7 devices

1-7 of 7

Cleared Aug 25, 2025

CRYOcheck Chromogenic Factor VIII

Hematology · 108d

Cleared Sep 13, 2023

CRYOcheck Factor VIII Deficient Plasma with VWF

Hematology · 359d

Cleared Dec 23, 2022

CRYOcheck Chromogenic Factor IX

Hematology · 367d

Cleared Mar 12, 2019

CRYOcheck FVIII Inhibitor Kit

Hematology · 90d

Cleared May 10, 2006

CRYOCHECK CLOT APCR

Hematology · 96d

Cleared Mar 18, 2005

CRYOCHECK CLOT S

Hematology · 81d

Cleared Jun 18, 2004

CRYOCHECK CLOT C

Hematology · 64d