OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY— 510(k) K980178

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K980178 for OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY, Substantially Equivalent on 1998-02-12. Applicant: Bionostics, Inc..

Clearance details

Applicant: Bionostics, Inc.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1998-01-20
Decision date: 1998-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

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