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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radial Immunodiffusion, Albumin
510(k) Number K811178
Device Name HUMAN IGG-ALBUMIN TEST KIT
Applicant
Meloy Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Meloy Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1035
Classification Product Code
CJQ  
Date Received04/28/1981
Decision Date 05/15/1981
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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