BIOTIS ABNORMAL CLINICAL CHEM SERUM-— 510(k) K840458

Substantially Equivalent

Otisville Biotech, Inc.

FDA 510(k) clearance K840458 for BIOTIS ABNORMAL CLINICAL CHEM SERUM-, Substantially Equivalent on 1984-04-17. Applicant: Otisville Biotech, Inc..

Clearance details

Applicant: Otisville Biotech, Inc.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1984-02-02
Decision date: 1984-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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