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FDA 510(k)

SEROZYME FREE T3 IMMUNOASSAY

K-Number: K902748 · 1990-08-09

ApplicantAdvanced Magnetics, Inc.
Decision Date1990-08-09
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SEROZYME FREE T3 IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Magnetics, Inc.. It received FDA 510(k) clearance on 1990-08-09 under 510(k) number K902748. 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 SEROZYME FREE T3 IMMUNOASSAY?

SEROZYME FREE T3 IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1990-08-09. The listed applicant is Advanced Magnetics, Inc.. The 510(k) number is K902748.

When did SEROZYME FREE T3 IMMUNOASSAY receive FDA 510(k) clearance?

SEROZYME FREE T3 IMMUNOASSAY received FDA 510(k) clearance on 1990-08-09, under 510(k) number K902748.

Who is the listed applicant for SEROZYME FREE T3 IMMUNOASSAY?

The FDA 510(k) record lists Advanced Magnetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEROZYME FREE T3 IMMUNOASSAY?

The FDA product code for SEROZYME FREE T3 IMMUNOASSAY is KHQ.

Related Clinical Trials

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.

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Other records listing Advanced Magnetics, Inc. 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.

K900060FREE T4 IMMUNOASSAY KITK894200FREE T3 RADIOIMMUNOASSAY KITK884753MODIFIED FREE T4 RADIOIMMUNOASSAY KIT

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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