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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Phenobarbital
510(k) Number K000012
Device Name IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Applicant Contact EDWARD M LEVINE
Correspondent
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Correspondent Contact EDWARD M LEVINE
Regulation Number862.3660
Classification Product Code
DLZ  
Date Received01/03/2000
Decision Date 03/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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