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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Types, Escherichia Coli
510(k) Number K933457
Device Name RIM E.COLI 0157:H7 LATEX TEST
Applicant
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Applicant Contact DAVID A WALL
Correspondent
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Correspondent Contact DAVID A WALL
Regulation Number866.3255
Classification Product Code
GNA  
Date Received07/14/1993
Decision Date 04/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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