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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Borrelia Serological Reagent
510(k) Number K896378
Device Name LYME-CHECK(TM) TEST KIT
Applicant
Diagnostic Technology, Inc.
240 Vanderbilt Motor Pkwy.
Hauppauge,  NY  11788
Applicant Contact IMRE PINTER
Correspondent
Diagnostic Technology, Inc.
240 Vanderbilt Motor Pkwy.
Hauppauge,  NY  11788
Correspondent Contact IMRE PINTER
Regulation Number866.3830
Classification Product Code
LSR  
Date Received11/06/1989
Decision Date 11/05/1991
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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