COLISCREEN— 510(k) K961191

Substantially Equivalent

Hardy Diagnostics

FDA 510(k) clearance K961191 for COLISCREEN, Substantially Equivalent on 1996-06-17. Applicant: Hardy Diagnostics.

Clearance details

Applicant: Hardy Diagnostics
Product code: Code JTO
Advisory panel: Microbiology
Date received: 1996-03-26
Decision date: 1996-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

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