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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bilirubin (Total And Unbound) In The Neonate Test System
510(k) Number K133175
Device Name DRAEGER JAUNDICE METER JM-105
Applicant
Draeger Medical Systems, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Applicant Contact BRYAN OVERTON
Correspondent
Draeger Medical Systems, Ind.
3135 Quarry Rd.
Telford,  PA  18969
Correspondent Contact BRYAN OVERTON
Regulation Number862.1113
Classification Product Code
MQM  
Date Received10/17/2013
Decision Date 11/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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