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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nephelometric Inhibition Immunoassay, Phenobarbital
510(k) Number K864612
Device Name DART PHENOBARBITAL ASSAY SYSTEM
Applicant
Coulter Electronics, Inc.
440 W. 20 St.
Hialeah,  FL  33010
Applicant Contact RICHARDSON-JONES
Correspondent
Coulter Electronics, Inc.
440 W. 20 St.
Hialeah,  FL  33010
Correspondent Contact RICHARDSON-JONES
Regulation Number862.3660
Classification Product Code
LFN  
Date Received11/24/1986
Decision Date 01/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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