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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Propoxyphene
510(k) Number K944372
Device Name STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA
Applicant
Solarcare, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018 -1799
Applicant Contact R. SAM NIEDBALA
Correspondent
Solarcare, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018 -1799
Correspondent Contact R. SAM NIEDBALA
Regulation Number862.3700
Classification Product Code
JXN  
Date Received09/07/1994
Decision Date 02/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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