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FDA 510(k)

ENZYME-TEST TBC T4 UPTAKE

K-Number: K820879 · 1982-04-16

ApplicantIcl Scientific
Decision Date1982-04-16
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYME-TEST TBC T4 UPTAKE is the device name listed in this FDA 510(k) record. The listed applicant is Icl Scientific. It received FDA 510(k) clearance on 1982-04-16 under 510(k) number K820879. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYME-TEST TBC T4 UPTAKE?

ENZYME-TEST TBC T4 UPTAKE is a medical device that received FDA 510(k) clearance on 1982-04-16. The listed applicant is Icl Scientific. The 510(k) number is K820879.

When did ENZYME-TEST TBC T4 UPTAKE receive FDA 510(k) clearance?

ENZYME-TEST TBC T4 UPTAKE received FDA 510(k) clearance on 1982-04-16, under 510(k) number K820879.

Who is the listed applicant for ENZYME-TEST TBC T4 UPTAKE?

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

What is the FDA product code for ENZYME-TEST TBC T4 UPTAKE?

The FDA product code for ENZYME-TEST TBC T4 UPTAKE is KHQ.

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Other records listing Icl Scientific as applicant

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K883942HYCOR SENTRY DRUGS OF ABUSE URINE CONTROLK843565KOVA TROL I,II, III HUMAN URINE-DRIEDK833761THERAPEUTIC DRUG CONTROLK832823ENZYMUNE-TEST TSHK831383EVENT-TEST SLIDEK823199ENZYME-TEST DIGOXIN

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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