ST AIA PACK HBA1C— 510(k) K100304

Substantially Equivalent

Tosoh Bioscience, Inc.

FDA 510(k) clearance K100304 for ST AIA PACK HBA1C, Substantially Equivalent on 2010-08-27. Applicant: Tosoh Bioscience, Inc..

Clearance details

Applicant: Tosoh Bioscience, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2010-02-03
Decision date: 2010-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Franciso, CA, US

Download summary PDF View on FDA.gov ↗

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