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FDA 510(k)

THROMBIN CLOTTING TIME REAGENT

K-Number: K920147 · 1992-05-01

ApplicantHelena Laboratories
Decision Date1992-05-01
Product CodeGJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBIN CLOTTING TIME REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1992-05-01 under 510(k) number K920147. 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 CLOTTING TIME REAGENT?

THROMBIN CLOTTING TIME REAGENT is a medical device that received FDA 510(k) clearance on 1992-05-01. The listed applicant is Helena Laboratories. The 510(k) number is K920147.

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

THROMBIN CLOTTING TIME REAGENT received FDA 510(k) clearance on 1992-05-01, under 510(k) number K920147.

Who is the listed applicant for THROMBIN CLOTTING TIME REAGENT?

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

What is the FDA product code for THROMBIN CLOTTING TIME REAGENT?

The FDA product code for THROMBIN CLOTTING TIME REAGENT is GJA.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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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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