TINA-QUANT COMPLEMENT C3C TEST SYSTEM— 510(k) K012361

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K012361 for TINA-QUANT COMPLEMENT C3C TEST SYSTEM, Substantially Equivalent on 2001-11-29. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code CZW
Advisory panel: Immunology
Date received: 2001-07-25
Decision date: 2001-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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