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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
510(k) Number K870318
Device Name AMEBIASIS ELISA TEST KIT
Applicant
Lmd Laboratories
4626 Santa Fe St.
San Diego,  CA  92109
Applicant Contact DAVE LAMBILLOTTE
Correspondent
Lmd Laboratories
4626 Santa Fe St.
San Diego,  CA  92109
Correspondent Contact DAVE LAMBILLOTTE
Regulation Number866.3220
Classification Product Code
KHW  
Date Received01/28/1987
Decision Date 08/11/1987
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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