ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL— 510(k) K032453

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K032453 for ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL, Substantially Equivalent on 2003-08-28. Applicant: Bionostics, Inc..

Clearance details

Applicant: Bionostics, Inc.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2003-08-11
Decision date: 2003-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Devens, MA, US

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