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FDA 510(k)

ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT

K-Number: K821553 · 1982-06-25

ApplicantAmf Biological and Diagnostics Co.
Decision Date1982-06-25
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amf Biological and Diagnostics Co.. It received FDA 510(k) clearance on 1982-06-25 under 510(k) number K821553. 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 ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT?

ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is Amf Biological and Diagnostics Co.. The 510(k) number is K821553.

When did ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT receive FDA 510(k) clearance?

ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT received FDA 510(k) clearance on 1982-06-25, under 510(k) number K821553.

Who is the listed applicant for ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT?

The FDA 510(k) record lists Amf Biological and Diagnostics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT?

The FDA product code for ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT is KHQ.

Related Clinical Trials

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Other records listing Amf Biological and Diagnostics 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.

K852418QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)K821931ZETA-CORTK821554ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KITK812329ZETA-SERA D

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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