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FDA 510(k)

SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)

K-Number: K911912 · 1991-09-18

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1991-09-18
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) is the device name listed in this FDA 510(k) record. The listed applicant is Serono-Baker Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-09-18 under 510(k) number K911912. 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 SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)?

SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) is a medical device that received FDA 510(k) clearance on 1991-09-18. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K911912.

When did SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) receive FDA 510(k) clearance?

SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) received FDA 510(k) clearance on 1991-09-18, under 510(k) number K911912.

Who is the listed applicant for SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)?

The FDA 510(k) record lists Serono-Baker Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)?

The FDA product code for SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) is KHQ.

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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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