TINA-QUANT ALPHA-1 ANTITRYPSIN— 510(k) K010978

Substantially Equivalent

Rochdiag

FDA 510(k) clearance K010978 for TINA-QUANT ALPHA-1 ANTITRYPSIN, Substantially Equivalent on 2001-05-18. Applicant: Rochdiag.

Clearance details

Applicant: Rochdiag
Product code: Code DEM
Advisory panel: Immunology
Date received: 2001-03-13
Decision date: 2001-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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