T3 UPTAKE-SQUIBB DIAGNOSTIC KIT— 510(k) K820340

Name: FDA 510(k) clearance K820340
Creator: U.S. Food and Drug Administration
Published: 1982-03-04

Substantially Equivalent

E. R. Squibb & Sons, Inc.

FDA 510(k) clearance K820340 for T3 UPTAKE-SQUIBB DIAGNOSTIC KIT, Substantially Equivalent on 1982-03-04. Applicant: E. R. Squibb & Sons, Inc.. Device class: 2.

Clearance details

Applicant: E. R. Squibb & Sons, Inc.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1982-02-08
Decision date: 1982-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHQ

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K961488 — ELECSYS T-UPTAKE ASSAY1996-06-12

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K821494 — RIA STAT 161982-06-03
K820616 — ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY1982-03-26
K820341 — CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT1982-03-04
K811240 — SUR-FIT LOOP OSTOMY O.R. SET1981-06-16
K811239 — SUR-FIT DISPOSABLE CONVEX INSERT1981-06-09

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