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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 K934388
Device Name QMS PHENOBARBITAL
Applicant
Seradyn, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Applicant Contact ANDRIS INDRIKSONS
Correspondent
Seradyn, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Correspondent Contact ANDRIS INDRIKSONS
Regulation Number862.3660
Classification Product Code
LFN  
Date Received09/09/1993
Decision Date 02/25/1994
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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