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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K861202
Device Name TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS
Applicant
Nms Pharmaceuticals, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Applicant Contact PERRY RUCKER
Correspondent
Nms Pharmaceuticals, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Correspondent Contact PERRY RUCKER
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/31/1986
Decision Date 01/09/1987
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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