Cryocheck Hex LA
FDA 510(k) K193556 · Precision Biologic
510(k) numberK193556
Submission
- Device name
- Cryocheck Hex LA
- Applicant
- Precision Biologic
Darmouth, CA - Received
- December 23, 2019
- Decision date
- October 23, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GFO – Activated Partial Thromboplastin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Specialty
- Hematology
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|---|---|---|---|
| K253957 | HemosIL Silica Clotting TimeGFO · Special | Instrumentation Laboratory (IL) Co. | 01/09/2026SE |
| K160445 | HemosIL Silica Clotting TimeGFO · Special | Instrumentation Laboratory CO | 03/16/2016SE |
| K053111 | Sta-Cephascreen KitGFO · Traditional | Diagnostica Stago, Inc. | 05/04/2006SE |
| K060688 | Hemosil SynthasilGFO · Special | Instrumentation Laboratory CO | 04/13/2006SE |
| K050221 | Hemosil Silica Clotting TimeGFO · Traditional | Instrumentation Laboratory CO | 03/30/2005SE |
| K022021 | Vital Scientific Aptt, Aptt & Quikcoag ApttGFO · Traditional | Vital Scientific N.V. | 11/01/2002SE |
| K014028 | Careside ApttGFO · Traditional | Careside Hemotology, Inc. | 02/08/2002SE |
| K014008 | Hemochron Jr. Citrate Aptt CuvetteGFO · Special | Itc, Inc. | 01/24/2002SE |
| K992712 | Sigma Diagnostics Alexin LS, Models A1219, A1334GFO · Traditional | Sigma Diagnostics, Inc. | 12/06/1999SE |
| K992711 | Sigma Diagnostics Alexin HS, Models A0969, A1094GFO · Traditional | Sigma Diagnostics, Inc. | 12/06/1999SE |
More from Sigma Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251440 | CRYOcheck Chromogenic Factor VIIIGGP · Traditional | 08/25/2025SE |
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWFGJT · Traditional | 09/13/2023SE |
| K214002 | CRYOcheck Chromogenic Factor IXGGP · Traditional | 12/23/2022SE |
| K193204 | Cryocheck Chromogenic Factor VIIIGGP · Traditional | 07/17/2020SE |
| K183440 | CRYOcheck FVIII Inhibitor KitGGP · Traditional | 03/12/2019SE |
| K060284 | Cryocheck Clot ApcrGGW · Traditional | 05/10/2006SE |
| K043571 | Cryocheck Clot SGGP · Traditional | 03/18/2005SE |
| K040987 | Cryocheck Clot CGGP · Traditional | 06/18/2004SE |
| K032804 | Cryocheck Weak Lupus Positive ControlGGC · Traditional | 11/03/2003SE |
| K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50JBQ · Traditional | 04/28/2003SE |
Questions and answers
When was Cryocheck Hex LA cleared by the FDA?
Cryocheck Hex LA (K193556) received a 510(k) decision of Substantially Equivalent on October 23, 2020, 305 days after the submission was received.
What is the product code of K193556?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.