DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III— 510(k) K892380

Name: FDA 510(k) clearance K892380
Creator: U.S. Food and Drug Administration
Published: 1990-02-08

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K892380 for DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III, Substantially Equivalent on 1990-02-08. Applicant: Baxter Healthcare Corp. Device class: 1.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DIF
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1989-04-06
Decision date: 1990-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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