ACCESS OSTASE IMMUNOENZYMETRIC ASSAY— 510(k) K994278

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K994278 for ACCESS OSTASE IMMUNOENZYMETRIC ASSAY, Substantially Equivalent on 2000-03-28. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code CIN
Advisory panel: Clinical Chemistry
Date received: 1999-12-20
Decision date: 2000-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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