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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cryptosporidium Spp.
510(k) Number K955345
Device Name LMD CRYPTOSPORIDIUM ANTIGEN DETECTION
Applicant
Lmd Laboratories
2792 Loker Ave., W., #103
Suite 103
Carlsbad,  CA  92008
Applicant Contact DAVID N LAMBILLOTTE
Correspondent
Lmd Laboratories
2792 Loker Ave., W., #103
Suite 103
Carlsbad,  CA  92008
Correspondent Contact DAVID N LAMBILLOTTE
Regulation Number866.3220
Classification Product Code
MHJ  
Date Received11/21/1995
Decision Date 06/07/1996
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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