STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.— 510(k) K895484

Name: FDA 510(k) clearance K895484
Creator: U.S. Food and Drug Administration
Published: 1989-10-04

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K895484 for STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO., Substantially Equivalent on 1989-10-04. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1989-09-11
Decision date: 1989-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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