SEROZYME FREE T3 IMMUNOASSAY— 510(k) K902748

Name: FDA 510(k) clearance K902748
Creator: U.S. Food and Drug Administration
Published: 1990-08-09

Substantially Equivalent

Advanced Magnetics, Inc.

FDA 510(k) clearance K902748 for SEROZYME FREE T3 IMMUNOASSAY, Substantially Equivalent on 1990-08-09. Applicant: Advanced Magnetics, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Magnetics, Inc.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1990-06-22
Decision date: 1990-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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K961488 — ELECSYS T-UPTAKE ASSAY1996-06-12

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K900060 — FREE T4 IMMUNOASSAY KIT1990-03-29
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Data sourced from openFDA. This site is unofficial and independent of the FDA.