HemosIL Factor V Leiden (APC Resistance V)
FDA 510(k) clearance K260551 · decided 2026-03-20
Clearance details
- K-number
- K260551
- Device name
- HemosIL Factor V Leiden (APC Resistance V)
- Applicant
- Instrumentation Laboratory (IL) Co.
- Decision
- Substantially Equivalent
- Date received
- 2026-02-18
- Decision date
- 2026-03-20
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- GGW
- Device class
- 2
- Regulation number
- 864.7925
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LUPOTEK KCT (K090105) | R2 Diagnostics, Inc. | 2010-12-30 |
| HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN (K083729) | Aniara Diagnostica, LLC | 2009-05-08 |
| CRYOCHECK CLOT APCR (K060284) | Precision Biologic, Inc. | 2006-05-10 |
| PEFAKIT APC-R FACTOR V LEIDEN (K042762) | Pentapharm , Ltd. | 2004-12-22 |
| PHOSPHOLIN ES AND CALCIUM CHLORIDE (K033471) | R2 Diagnostics, Inc. | 2004-02-04 |
| GRADILEIDEN V TEST (K992456) | Gradipore , Ltd. | 1999-12-21 |
| CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 (K982062) | Precision Biologicals, Inc. | 1999-01-13 |
| COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S (K963111) | Chromogenix AB | 1996-12-23 |
| COATEST(R) APC(TM) RESISTANCE (K945940) | Axis-Shield Doc AS | 1995-08-07 |
| PTT-LT TEST KIT (K941210) | American Bioproducts Co. | 1995-03-21 |
| STACLOT(R) PNP TEST KIT (K924370) | American Bioproducts Co. | 1993-08-09 |
| PTT-LA TEST KIT (K921684) | American Bioproducts Co. | 1992-06-09 |
Recalls involving this device
No recalls on record reference this clearance.