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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wright'S Stain
510(k) Number K854236
Device Name HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS
Applicant
Nms Pharmaceuticals, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Applicant Contact PERRY C RUCKER
Correspondent
Nms Pharmaceuticals, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Correspondent Contact PERRY C RUCKER
Regulation Number864.1850
Classification Product Code
IAF  
Date Received10/21/1985
Decision Date 10/10/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Hematology
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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