HemosIL Factor V Leiden (APC Resistance V)
FDA 510(k) K260551 · Instrumentation Laboratory (IL) Co.
510(k) numberK260551
Submission
- Device name
- HemosIL Factor V Leiden (APC Resistance V)
- Applicant
- Instrumentation Laboratory (IL) Co.
Bedford, MA, US - Received
- February 18, 2026
- Decision date
- March 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGW – Test, Time, Partial Thromboplastin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Specialty
- Hematology
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| K090105 | Lupotek KCTGGW · Traditional | R2 Diagnostics, Inc. | 12/30/2010SE |
| K083729 | Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act.…GGW · Traditional | Aniara Diagnostica, LLC | 05/08/2009SE |
| K060284 | Cryocheck Clot ApcrGGW · Traditional | Precision Biologic, Inc. | 05/10/2006SE |
| K042762 | Pefakit Apc-R Factor V LeidenGGW · Traditional | Pentapharm , Ltd. | 12/22/2004SE |
| K033471 | Phospholin Es and Calcium ChlorideGGW · Traditional | R2 Diagnostics, Inc. | 02/04/2004SE |
| K992456 | Gradileiden V TestGGW · Traditional | Gradipore , Ltd. | 12/21/1999SE |
| K982062 | Cryo-Check PNP Platelet Lysate, Model PNP-10GGW · Traditional | Precision Biologicals, Inc. | 01/13/1999SE |
| K963111 | Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V SGGW · Traditional | Chromogenix AB | 12/23/1996SE |
| K945940 | Coatest(R) Apc(Tm) ResistanceGGW · Traditional | Axis-Shield Doc AS | 08/07/1995SE |
| K941210 | Ptt-Lt Test KitGGW · Traditional | American Bioproducts Co. | 03/21/1995SESK |
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| K243374 | HemosIL CL HIT-IgG(PF4-H)LCO · Traditional | 01/28/2025SE |
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Questions and answers
When was HemosIL Factor V Leiden (APC Resistance V) cleared by the FDA?
HemosIL Factor V Leiden (APC Resistance V) (K260551) received a 510(k) decision of Substantially Equivalent on March 20, 2026, 30 days after the submission was received.
What is the product code of K260551?
The FDA product code is GGW – Test, Time, Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.