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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Immunoassay, Phenobarbital
510(k) Number K901537
Device Name MODIFIED OPUS PHENOBARBITAL TEST SYSTEM
Applicant
Pb Diagnostic Systems, Inc.
151 University Ave.
Westwood,  MA  02090
Applicant Contact LORI BARANAUSKAS
Correspondent
Pb Diagnostic Systems, Inc.
151 University Ave.
Westwood,  MA  02090
Correspondent Contact LORI BARANAUSKAS
Regulation Number862.3660
Classification Product Code
LET  
Date Received04/02/1990
Decision Date 06/12/1990
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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