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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fluorescence polarization immunoassay, tobramycin
510(k) Number K912143
Device Name CEDIA(R) TOBRAMYCIN ASSAY
Applicant
MICROGENICS CORP.
2380A BISSO LN.
CONCORD,  CA  94520
Applicant Contact Patricia M Klimley
Correspondent
MICROGENICS CORP.
2380A BISSO LN.
CONCORD,  CA  94520
Correspondent Contact Patricia M Klimley
Regulation Number862.3900
Classification Product Code
LFW  
Date Received05/15/1991
Decision Date 07/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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