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FDA 510(k)

STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY

K-Number: K860422 · 1986-04-11

ApplicantAmerican Dade
Decision Date1986-04-11
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1986-04-11 under 510(k) number K860422. 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 STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY?

STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1986-04-11. The listed applicant is American Dade. The 510(k) number is K860422.

When did STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1986-04-11, under 510(k) number K860422.

Who is the listed applicant for STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY?

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 STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY?

The FDA product code for STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY is KHQ.

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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

View all 149 devices →

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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