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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K850431
Device Name EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
Applicant
Nms Pharmaceuticals, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Applicant Contact PERRY G RUCKER
Correspondent
Nms Pharmaceuticals, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Correspondent Contact PERRY G RUCKER
Regulation Number864.6550
Classification Product Code
KHE  
Date Received02/04/1985
Decision Date 06/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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