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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 K875286
Device Name LYME STAT TEST KIT
Applicant
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Applicant Contact MARIE P REEVES
Correspondent
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Correspondent Contact MARIE P REEVES
Regulation Number866.3830
Classification Product Code
LSR  
Date Received12/29/1987
Decision Date 03/30/1988
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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