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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, Mumps Virus
510(k) Number K830045
Device Name MUMPSELISA 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 Number866.3380
Classification Product Code
LJY  
Date Received01/10/1983
Decision Date 05/13/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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