STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY— 510(k) K874438

Name: FDA 510(k) clearance K874438
Creator: U.S. Food and Drug Administration
Published: 1988-01-21

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K874438 for STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1988-01-21. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code LEH
Device class: Class 2
Regulation: 21 CFR 862.3950
Advisory panel: Clinical Toxicology
Date received: 1987-10-28
Decision date: 1988-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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