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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Alt/Sgpt
510(k) Number K941497
Device Name SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY
Applicant
Solarcare, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018 -1799
Applicant Contact R. SAM NEIDBALA
Correspondent
Solarcare, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018 -1799
Correspondent Contact R. SAM NEIDBALA
Regulation Number862.1030
Classification Product Code
CKA  
Date Received03/28/1994
Decision Date 05/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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