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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 K992127
Device Name CARDIOQUANT TROPONIN I TEST
Applicant
Spectral Diagnostics, Inc.
5550 NW 102 Pl.
Miami,  FL  33178
Applicant Contact FRANCEE S BOCHES
Correspondent
Spectral Diagnostics, Inc.
5550 NW 102 Pl.
Miami,  FL  33178
Correspondent Contact FRANCEE S BOCHES
Regulation Number862.1215
Classification Product Code
MMI  
Date Received06/23/1999
Decision Date 10/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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