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. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code PDJ
Device class: Class 2
Regulation: 21 CFR 862.1373
Advisory panel: Clinical Chemistry
Date received: 2013-03-25
Decision date: 2013-05-23
Decision: Unknown
Clearance type: Post-NSE
Location: Indianapolis, IN, US

View on FDA.gov ↗

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