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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Types, Escherichia Coli
510(k) Number K942705
Device Name E. COLI 0157 ELISA STOOL ASSAY
Applicant
Lmd Laboratories
2792 Loker Ave., W., #103
Suite 103
Carlsbad,  CA  92008
Applicant Contact DAVE LAMBILLOTTE
Correspondent
Lmd Laboratories
2792 Loker Ave., W., #103
Suite 103
Carlsbad,  CA  92008
Correspondent Contact DAVE LAMBILLOTTE
Regulation Number866.3255
Classification Product Code
GMZ  
Date Received06/08/1994
Decision Date 09/27/1995
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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