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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, Barbiturate
510(k) Number K001976
Device Name STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
Applicant
OraSure Technologies, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018 -1799
Applicant Contact R. SAM NIEDBALA
Correspondent
OraSure Technologies, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018 -1799
Correspondent Contact R. SAM NIEDBALA
Regulation Number862.3150
Classification Product Code
DIS  
Date Received06/29/2000
Decision Date 12/06/2000
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
Recalls CDRH Recalls
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