DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III— 510(k) K903566

Name: FDA 510(k) clearance K903566
Creator: U.S. Food and Drug Administration
Published: 1990-09-24

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K903566 for DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III, Substantially Equivalent on 1990-09-24. Applicant: Baxter Healthcare Corp. Device class: 1.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1990-08-07
Decision date: 1990-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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