Coamatic Factor Viii
FDA 510(k) K943225 · Pharmacia Hepar, Inc.
510(k) numberK943225
Submission
- Device name
- Coamatic Factor Viii
- Applicant
- Pharmacia Hepar, Inc.
Franklin, OH, US - Received
- July 6, 1994
- Decision date
- November 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K193204 | Cryocheck Chromogenic Factor VIIIGGP · Traditional | Precision Biologic | 07/17/2020SE |
| 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 |
Questions and answers
When was Coamatic Factor Viii cleared by the FDA?
Coamatic Factor Viii (K943225) received a 510(k) decision of Substantially Equivalent on November 6, 1995, 488 days after the submission was received.
What is the product code of K943225?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.