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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
510(k) Number K821762
Device Name MEASELISA TEST KIT
Applicant
M.A. Bioproducts
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
M.A. Bioproducts
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3520
Classification Product Code
LJB  
Date Received06/15/1982
Decision Date 07/30/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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