CRYOcheck Chromogenic Factor IX— 510(k) K214002

Name: FDA 510(k) clearance K214002
Creator: U.S. Food and Drug Administration
Published: 2022-12-23

Substantially Equivalent

Precision Biologic, Inc.

FDA 510(k) clearance K214002 for CRYOcheck Chromogenic Factor IX, Substantially Equivalent on 2022-12-23. Applicant: Precision Biologic, Inc.. Device class: 2.

Clearance details

Applicant: Precision Biologic, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2021-12-21
Decision date: 2022-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Darmouth, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGP

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K251440 — CRYOcheck Chromogenic Factor VIII2025-08-25
K230852 — HemosIL Chromogenic Factor IX2023-12-13
K220728 — vWF Ag2023-06-02
K223402 — HemosIL von Willebrand Factor Antigen2022-12-09
K200033 — HemosIL von Willebrand Factor Antigen2020-08-19

More clearances from Precision Biologic, Inc.

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K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF2023-09-13
K183440 — CRYOcheck FVIII Inhibitor Kit2019-03-12
K060284 — CRYOCHECK CLOT APCR2006-05-10
K043571 — CRYOCHECK CLOT S2005-03-18
K040987 — CRYOCHECK CLOT C2004-06-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.