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FDA 510(k)

ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589

K-Number: K982209 · 1998-10-15

ApplicantSigma Diagnostics, Inc.
Decision Date1998-10-15
Product CodeGJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-10-15 under 510(k) number K982209. The device is classified under product code GJA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589?

ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 is a medical device that received FDA 510(k) clearance on 1998-10-15. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K982209.

When did ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 receive FDA 510(k) clearance?

ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 received FDA 510(k) clearance on 1998-10-15, under 510(k) number K982209.

Who is the listed applicant for ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589?

The FDA 510(k) record lists Sigma Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589?

The FDA product code for ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 is GJA.

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Other records listing Sigma Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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Related Devices (Code: GJA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K050817T-TEKR2 Diagnostics, Inc.K970645BC THROMBIN REAGENTBehring Diagnostics, Inc.K925493BIOMERIEUX HEMOLAB THROMBICALCI-TESTBiomerieux Vitek, Inc.K930157TEST THROMBINBehring Diagnostics, Inc.K923220THROMBIN CLOT TIME TEST PROCEDUREMedical Laboratory Automation Systems, Inc.K920147THROMBIN CLOTTING TIME REAGENTHelena Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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