ST AIA-PACK CYSTATIN C, MODEL 025217— 510(k) K093960

Substantially Equivalent

Tosoh Bioscience, Inc.

FDA 510(k) clearance K093960 for ST AIA-PACK CYSTATIN C, MODEL 025217, Substantially Equivalent on 2010-09-14. Applicant: Tosoh Bioscience, Inc..

Clearance details

Applicant: Tosoh Bioscience, Inc.
Product code: Code NDY
Advisory panel: Clinical Chemistry
Date received: 2009-12-23
Decision date: 2010-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Franciso, CA, US

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