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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K042227
Device Name INSTANT-VIEW TROPONIN I TEST
Applicant
Alfa Scientific Designs, Inc.
12330 Stowe Dr.
Poway,  CA  92064
Applicant Contact NAISHU WANG
Correspondent
Alfa Scientific Designs, Inc.
12330 Stowe Dr.
Poway,  CA  92064
Correspondent Contact NAISHU WANG
Regulation Number862.1215
Classification Product Code
MMI  
Date Received08/17/2004
Decision Date 11/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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