BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT— 510(k) K900546

Name: FDA 510(k) clearance K900546
Creator: U.S. Food and Drug Administration
Published: 1990-06-15

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K900546 for BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT, Substantially Equivalent on 1990-06-15. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code GTH
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1990-02-05
Decision date: 1990-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

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