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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, Phencyclidine
510(k) Number K982801
Device Name AUTO-LYTE PCP EIA, MODEL #1254U
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
Classification Product Code
LCM  
Date Received08/10/1998
Decision Date 11/04/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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