IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT— 510(k) K050352

Name: FDA 510(k) clearance K050352
Creator: U.S. Food and Drug Administration
Published: 2005-09-01

Substantially Equivalent

Ameritek Research, LLC

FDA 510(k) clearance K050352 for IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT, Substantially Equivalent on 2005-09-01. Applicant: Ameritek Research, LLC. Device class: 1.

Clearance details

Applicant: Ameritek Research, LLC
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2005-02-11
Decision date: 2005-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mill Creek, WA, US

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