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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Cysticercosis
510(k) Number K900780
Device Name CYSTICERCOSIS SEROLOGICAL REAGENTS
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 Number866.3200
Classification Product Code
MDJ  
Date Received02/20/1990
Decision Date 10/04/1990
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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