URI-THREE(TM), MODIFICATION— 510(k) K911846

Substantially Equivalent

Culture Kits, Inc.

FDA 510(k) clearance K911846 for URI-THREE(TM), MODIFICATION, Substantially Equivalent on 1991-10-04. Applicant: Culture Kits, Inc.. Device class: 1.

Clearance details

Applicant: Culture Kits, Inc.
Product code: Code JXA
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1991-04-18
Decision date: 1991-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwich, NY, US

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