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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exoenzymes, Multiple, Streptococcal
510(k) Number K860041
Device Name STREP D FLUOR
Applicant
Bio Spec, Inc.
179 Mason Circle #A
Concord,  CA  94520
Applicant Contact ROBERT F HIRD
Correspondent
Bio Spec, Inc.
179 Mason Circle #A
Concord,  CA  94520
Correspondent Contact ROBERT F HIRD
Regulation Number866.3720
Classification Product Code
GTP  
Date Received01/06/1986
Decision Date 01/24/1986
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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