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FDA 510(k)

THROMBIN TIME REAGENT

K-Number: K894467 · 1989-09-05

ApplicantSigma Chemical Co.
Decision Date1989-09-05
Product CodeGJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBIN TIME REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1989-09-05 under 510(k) number K894467. 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 THROMBIN TIME REAGENT?

THROMBIN TIME REAGENT is a medical device that received FDA 510(k) clearance on 1989-09-05. The listed applicant is Sigma Chemical Co.. The 510(k) number is K894467.

When did THROMBIN TIME REAGENT receive FDA 510(k) clearance?

THROMBIN TIME REAGENT received FDA 510(k) clearance on 1989-09-05, under 510(k) number K894467.

Who is the listed applicant for THROMBIN TIME REAGENT?

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

What is the FDA product code for THROMBIN TIME REAGENT?

The FDA product code for THROMBIN TIME REAGENT is GJA.

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Other records listing Sigma Chemical Co. 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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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.K982209ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589Sigma 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.

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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