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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 K844141
Device Name ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC)
Applicant
Lmd Laboratories
8933 Lombard Pl. #215
San Diego,  CA  2122
Applicant Contact DAVID N LAMBILLOTTE
Correspondent
Lmd Laboratories
8933 Lombard Pl. #215
San Diego,  CA  2122
Correspondent Contact DAVID N LAMBILLOTTE
Regulation Number866.3220
Classification Product Code
KHW  
Date Received10/23/1984
Decision Date 12/06/1984
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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