Cryocheck Chromogenic Factor VIII
FDA 510(k) K193204 · Precision Biologic
510(k) numberK193204
Submission
- Device name
- Cryocheck Chromogenic Factor VIII
- Applicant
- Precision Biologic
Darmouth, CA - Received
- November 20, 2019
- Decision date
- July 17, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
Other 510(k)s with product code GGP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251440 | CRYOcheck Chromogenic Factor VIIIGGP · Traditional | Precision Biologic, Inc. | 08/25/2025SE |
| K230852 | HemosIL Chromogenic Factor IXGGP · Traditional | Instrumentation Laboratory Company | 12/13/2023SE |
| K220728 | vWF AgGGP · Traditional | Siemens Healthcare Diagnostics Products GmbH | 06/02/2023SE |
| K214002 | CRYOcheck Chromogenic Factor IXGGP · Traditional | Precision Biologic, Inc. | 12/23/2022SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | Instrumentation Laboratory CO | 12/09/2022SE |
| K200033 | HemosIL von Willebrand Factor AntigenGGP · Special | Instrumentation Laboratory CO | 08/19/2020SE |
| K183440 | CRYOcheck FVIII Inhibitor KitGGP · Traditional | Precision Biologic, Inc. | 03/12/2019SE |
| K181525 | INNOVANCE Free PS AgGGP · Traditional | Siemens Healthcare Diagnostics Products GmbH | 09/07/2018SE |
| K133005 | Hemosil Von Willebrand Activity AssayGGP · Special | Instrumentation Laboratory CO | 03/13/2014SE |
| K102164 | Hemosil Protein S Activity AssayGGP · Traditional | Instrumentation Laboratory CO | 03/17/2011SE |
More from Instrumentation Laboratory CO
| 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 |
| K193556 | Cryocheck Hex LAGFO · Traditional | 10/23/2020SE |
| 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 Chromogenic Factor VIII cleared by the FDA?
Cryocheck Chromogenic Factor VIII (K193204) received a 510(k) decision of Substantially Equivalent on July 17, 2020, 240 days after the submission was received.
What is the product code of K193204?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.