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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Control For Nontreponemal Tests
510(k) Number K955143
Device Name RPR LIQUID CONTROLS
Applicant
Remel, L.P.
P.O. Box 16276
Augusta,  GA  30919
Applicant Contact DAVID A WALL
Correspondent
Remel, L.P.
P.O. Box 16276
Augusta,  GA  30919
Correspondent Contact DAVID A WALL
Regulation Number866.3820
Classification Product Code
GMP  
Date Received11/13/1995
Decision Date 07/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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