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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm, Antigen, Antiserum, Control
510(k) Number K830606
Device Name QUIK-SEP IGM ISOLATION SYSTEM
Applicant
Isolab, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Isolab, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5550
Classification Product Code
DFT  
Date Received02/25/1983
Decision Date 03/24/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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