TINA-QUANT HBA1C GEN. 2 TEST SYSTEM— 510(k) DEN130002

Unknown

Roche Diagnostics

FDA 510(k) clearance DEN130002 for TINA-QUANT HBA1C GEN. 2 TEST SYSTEM, Unknown on 2013-05-23. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code PDJ
Advisory panel: Clinical Chemistry
Date received: 2013-03-25
Decision date: 2013-05-23
Decision: Unknown
Clearance type: Post-NSE
Location: Indianapolis, IN, US

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