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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agglutination Method, Human Chorionic Gonadotropin
510(k) Number K802450
Device Name GESTATE SLIDE EIKEN KIT AGG. METHOD HUM
Applicant
Syn-Kit, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Syn-Kit, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received10/08/1980
Decision Date 10/31/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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