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FDA 510(k)

THROMBIN TIME TEST

K-Number: K822466 · 1982-09-14

ApplicantAmerican Dade
Decision Date1982-09-14
Product CodeGJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBIN TIME TEST is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1982-09-14 under 510(k) number K822466. 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 TEST?

THROMBIN TIME TEST is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is American Dade. The 510(k) number is K822466.

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

THROMBIN TIME TEST received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822466.

Who is the listed applicant for THROMBIN TIME TEST?

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

What is the FDA product code for THROMBIN TIME TEST?

The FDA product code for THROMBIN TIME TEST is GJA.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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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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