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Panels › Hematology › Product code GFO · Class 2

Activated Partial Thromboplastin

Regulation 864.7925

1510(k)s in 12 months (52 all time)
2recalls in 12 months (10 all time)
8recalls that name a 510(k)
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Top companies in GFO

Company510(k)sRecalls
Instrumentation Laboratory CO42
Analytical Control Systems, Inc.50
International Technidyne Corp.50
Diagnostica Stago, Inc.13
Helena Laboratories22
Medical Diagnostic Technologies, Inc.30
Behring Diagnostics, Inc.20
Elite Diagnostic , Ltd.20
Hyland Therapeutic Div., Travenol Laboratories20
Ortho Diagnostic Systems, Inc.20
DateFirm and productCodeLinked 510(k)
Jan 15, 2026Instrumentation Laboratory
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Open, Classified		 GFOK060688
Dec 17, 2025Instrumentation Laboratory
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Open, Classified		 GFOK955638
Jan 5, 2021Helena Laboratories, Corp.
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated wh
Terminated		 GFONone listed
Sep 27, 2019Helena Laboratories, Corp.
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Terminated		 GFONone listed
Nov 14, 2018Diagnostica Stago, Inc.
Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII pha
Terminated		 GFOK923731
Nov 14, 2018Diagnostica Stago, Inc.
Staclot LA (REF 00600) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase
Terminated		 GFOK923731
Jun 2, 2015Siemens Healthcare Diagnostics, Inc.
Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation p
Terminated		 GFOK760318
Feb 6, 2014ITC-Nexus Dx
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of lo
Terminated		 GFOK014008
Aug 26, 2006Diagnostica Stago, Inc.
Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.
Terminated		 GFOK923731
Jul 20, 2004Dade Behring , Inc.
Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials
Terminated		 GFOK955450

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