T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS— 510(k) K883085

Name: FDA 510(k) clearance K883085
Creator: U.S. Food and Drug Administration
Published: 1988-09-09

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K883085 for T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS, Substantially Equivalent on 1988-09-09. Applicant: Serono Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1988-07-22
Decision date: 1988-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

Download summary PDF View on FDA.gov ↗

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K961488 — ELECSYS T-UPTAKE ASSAY1996-06-12

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K880388 — T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE1988-03-03
K874866 — T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE1988-02-11

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