CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)— 510(k) K913133

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K913133 for CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED), Substantially Equivalent on 1991-09-27. Applicant: Bionostics, Inc..

Clearance details

Applicant: Bionostics, Inc.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1991-07-16
Decision date: 1991-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.