STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO— 510(k) K933426

Name: FDA 510(k) clearance K933426
Creator: U.S. Food and Drug Administration
Published: 1993-08-26

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K933426 for STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO, Substantially Equivalent on 1993-08-26. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1993-07-13
Decision date: 1993-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-1161993-10-18

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