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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Antitrypsin, Antigen, Antiserum, Control
510(k) Number K010978
Device Name TINA-QUANT ALPHA-1 ANTITRYPSIN
Applicant
Rochdiag
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact KAY A TAYLOR
Correspondent
Rochdiag
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact KAY A TAYLOR
Regulation Number866.5130
Classification Product Code
DEM  
Date Received03/13/2001
Decision Date 05/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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