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510(k) K251440

CRYOcheck Chromogenic Factor VIII by Precision Biologic, Inc. — Product Code GGP

K251440 is an FDA 510(k) premarket notification submitted by Precision Biologic, Inc. for the device "CRYOcheck Chromogenic Factor VIII". The FDA issued a decision of Substantially Equivalent on August 25, 2025. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Precision Biologic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2025
Date Received
May 9, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Qualitative And Quantitative Factor Deficiency
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type

Other clearances by Precision Biologic, Inc.

  • K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF (September 13, 2023)
  • K214002 — CRYOcheck Chromogenic Factor IX (December 23, 2022)
  • K193556 — Cryocheck Hex LA (October 23, 2020)
  • K193204 — Cryocheck Chromogenic Factor VIII (July 17, 2020)
  • K183440 — CRYOcheck FVIII Inhibitor Kit (March 12, 2019)
  • K060284 — CRYOCHECK CLOT APCR (May 10, 2006)
  • K043571 — CRYOCHECK CLOT S (March 18, 2005)
  • K040987 — CRYOCHECK CLOT C (June 18, 2004)
  • K032804 — CRYOCHECK WEAK LUPUS POSITIVE CONTROL (November 3, 2003)
  • K023991 — CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (April 28, 2003)

Other clearances for product code GGP

  • K230852 — HemosIL Chromogenic Factor IX (December 13, 2023)
  • K220728 — vWF Ag (June 2, 2023)
  • K214002 — CRYOcheck Chromogenic Factor IX (December 23, 2022)
  • K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
  • K200033 — HemosIL von Willebrand Factor Antigen (August 19, 2020)
  • K193204 — Cryocheck Chromogenic Factor VIII (July 17, 2020)
  • K183440 — CRYOcheck FVIII Inhibitor Kit (March 12, 2019)
  • K181525 — INNOVANCE Free PS Ag (September 7, 2018)
  • K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (March 13, 2014)
  • K102164 — HEMOSIL PROTEIN S ACTIVITY ASSAY (March 17, 2011)

FDA data resources