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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K925649
Device Name NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY
Applicant
SOLARCARE TECHNOLOGIES CORP,INC.
1745 EATON AVE.
BETHLEHEM,  PA  18018 -1799
Applicant Contact SAM NIEDBALA
Correspondent
SOLARCARE TECHNOLOGIES CORP,INC.
1745 EATON AVE.
BETHLEHEM,  PA  18018 -1799
Correspondent Contact SAM NIEDBALA
Regulation Number862.1695
Classification Product Code
CEC  
Date Received11/09/1992
Decision Date 03/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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