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510(k) K260551

Device
HemosIL Factor V Leiden (APC Resistance V)
Applicant
Instrumentation Laboratory (IL) Co.
510(k) number
K260551
Product code
GGW
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-20
Date received
2026-02-18
Regulation
864.7925
Classification name
Test, Time, Partial Thromboplastin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Kirivann Chhoeun
Address
180 Hartwell Rd. Bedford MA US 01730 01730

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GGW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K090105LUPOTEK KCTR2 Diagnostics, Inc.2010-12-30
K083729HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHENAniara Diagnostica, LLC2009-05-08
K060284CRYOCHECK CLOT APCRPrecision Biologic, Inc.2006-05-10
K042762PEFAKIT APC-R FACTOR V LEIDENPentapharm , Ltd.2004-12-22
K033471PHOSPHOLIN ES AND CALCIUM CHLORIDER2 Diagnostics, Inc.2004-02-04
K992456GRADILEIDEN V TESTGradipore , Ltd.1999-12-21
K982062CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10Precision Biologicals, Inc.1999-01-13
K963111COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V SChromogenix AB1996-12-23
K945940COATEST(R) APC(TM) RESISTANCEAxis-Shield Doc AS1995-08-07
K941210PTT-LT TEST KITAmerican Bioproducts Co.1995-03-21
K924370STACLOT(R) PNP TEST KITAmerican Bioproducts Co.1993-08-09
K921684PTT-LA TEST KITAmerican Bioproducts Co.1992-06-09
K915463ACTIVATED PARTIAL THROMBOPLASTIN TIMESigma Diagnostics, Inc.1992-01-23
K902236READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KITBiosearch Medical Products, Inc.1990-08-14
K873382PLATELET EXTRACT REAGENTBio/Data Corp.1987-11-20