T-UPTAKE MICROASSAY— 510(k) K885034

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K885034 for T-UPTAKE MICROASSAY, Substantially Equivalent on 1989-02-02. Applicant: Diamedix Corp.. Device class: 2.

Clearance details

Applicant: Diamedix Corp.
Product code: Code CEE
Device class: Class 2
Regulation: 21 CFR 862.1685
Advisory panel: Clinical Chemistry
Date received: 1988-12-05
Decision date: 1989-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEE

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K905777 — MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT1991-01-30
K900240 — DELFIA TBG KIT1990-03-30

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Data sourced from openFDA. This site is unofficial and independent of the FDA.