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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lambda, Antigen, Antiserum, Control
510(k) Number K832261
Device Name GOAT ANTI-HUMAN LAMBA AFFINITY
Applicant
Gelco Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Gelco Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5550
Classification Product Code
DEH  
Date Received06/30/1983
Decision Date 10/28/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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