HemosIL Chromogenic Factor IX
FDA 510(k) K230852 · Instrumentation Laboratory Company
510(k) numberK230852
Submission
- Device name
- HemosIL Chromogenic Factor IX
- Applicant
- Instrumentation Laboratory Company
Bedford, MA, US - Received
- March 28, 2023
- Decision date
- December 13, 2023
- 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 |
| 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 |
| K102164 | Hemosil Protein S Activity AssayGGP · Traditional | Instrumentation Laboratory CO | 03/17/2011SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K233790 | Acl Top 970 CLJPA · Special | 12/29/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | 09/29/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | 06/23/2023SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | 08/16/2022SE |
| K203790 | GEM Premier 5000CHL · Special | 08/20/2021SE |
Questions and answers
When was HemosIL Chromogenic Factor IX cleared by the FDA?
HemosIL Chromogenic Factor IX (K230852) received a 510(k) decision of Substantially Equivalent on December 13, 2023, 260 days after the submission was received.
What is the product code of K230852?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.