FDA 510(k)

T3 UPTAKE-SQUIBB DIAGNOSTIC KIT

K-Number: K820340 · 1982-03-04

Decision Date1982-03-04

Product CodeKHQ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

T3 UPTAKE-SQUIBB DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is E. R. Squibb & Sons, Inc.. It received FDA 510(k) clearance on 1982-03-04 under 510(k) number K820340. 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 T3 UPTAKE-SQUIBB DIAGNOSTIC KIT?

T3 UPTAKE-SQUIBB DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1982-03-04. The listed applicant is E. R. Squibb & Sons, Inc.. The 510(k) number is K820340.

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

T3 UPTAKE-SQUIBB DIAGNOSTIC KIT received FDA 510(k) clearance on 1982-03-04, under 510(k) number K820340.

Who is the listed applicant for T3 UPTAKE-SQUIBB DIAGNOSTIC KIT?

The FDA 510(k) record lists E. R. Squibb & Sons, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing E. R. Squibb & Sons, Inc. as applicant

K821494RIA STAT 16 K820616ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY K820341CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT K811240SUR-FIT LOOP OSTOMY O.R. SET K811239SUR-FIT DISPOSABLE CONVEX INSERT K811160SUR-FIT IRRIGATION SLEEVE

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Related Devices (Code: KHQ)

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobind K970539CHIRON 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.