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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Streptococcus Spp.
510(k) Number K861098
Device Name SEROIDEN STREPTO KIT 'EIKEN'
Applicant
Syn-Kit, Inc.
9231 Eton Ave.
Chatsworth,  CA  91311
Applicant Contact JAMES F GODFREY
Correspondent
Syn-Kit, Inc.
9231 Eton Ave.
Chatsworth,  CA  91311
Correspondent Contact JAMES F GODFREY
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received03/24/1986
Decision Date 08/12/1986
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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