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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 K905598
Device Name CRYPTOSPORIDIUM ANTIGEN DETECTION
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
MHJ  
Date Received12/13/1990
Decision Date 09/05/1991
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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