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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
510(k) Number K860641
Device Name EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93
Applicant
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact RAYMOND L MILLER
Correspondent
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact RAYMOND L MILLER
Regulation Number862.3240
Classification Product Code
DLI  
Date Received02/20/1986
Decision Date 04/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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