TINA-QUANT ALBUMIN GEN 2— 510(k) K101203

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K101203 for TINA-QUANT ALBUMIN GEN 2, Substantially Equivalent on 2010-09-10. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code DCF
Advisory panel: Immunology
Date received: 2010-04-29
Decision date: 2010-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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