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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 K911590
Device Name IMMUNOWELL BORRELIA (LYME)TEST
Applicant
General Biometrics, Inc.
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Applicant Contact BRYAN L KIEHL
Correspondent
General Biometrics, Inc.
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Correspondent Contact BRYAN L KIEHL
Regulation Number866.3830
Classification Product Code
LSR  
Date Received04/09/1991
Decision Date 12/20/1991
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
Recalls CDRH Recalls
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