HemosIL Silica Clotting Time
FDA 510(k) K253957 · Instrumentation Laboratory (IL) Co.
510(k) numberK253957
Submission
- Device name
- HemosIL Silica Clotting Time
- Applicant
- Instrumentation Laboratory (IL) Co.
Bedford, MA, US - Received
- December 10, 2025
- Decision date
- January 9, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code GFO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193556 | Cryocheck Hex LAGFO · Traditional | Precision Biologic | 10/23/2020SE |
| 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 |
|---|---|---|
| K260551 | HemosIL Factor V Leiden (APC Resistance V)GGW · Special | 03/20/2026SE |
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLKQJ · Special | 07/24/2025SE |
| K243374 | HemosIL CL HIT-IgG(PF4-H)LCO · Traditional | 01/28/2025SE |
| K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550…GKP · Special | 08/16/2024SE |
Questions and answers
When was HemosIL Silica Clotting Time cleared by the FDA?
HemosIL Silica Clotting Time (K253957) received a 510(k) decision of Substantially Equivalent on January 9, 2026, 30 days after the submission was received.
What is the product code of K253957?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.