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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
510(k) Number K883720
Device Name TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA
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 Number866.3780
Classification Product Code
LGD  
Date Received08/31/1988
Decision Date 01/24/1989
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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