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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Iha, Toxoplasma Gondii
510(k) Number K802452
Device Name TOXOTEST-MT EIKEN KIT
Applicant
Syn-Kit, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Syn-Kit, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3780
Classification Product Code
GMM  
Date Received10/08/1980
Decision Date 12/18/1980
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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