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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 K021622
Device Name HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103
Applicant
Hill-Rom Air-Shields
330 Jacksonville Rd.
Hatboro,  PA  19040
Applicant Contact MONICA FERRANTE
Correspondent
Hill-Rom Air-Shields
330 Jacksonville Rd.
Hatboro,  PA  19040
Correspondent Contact MONICA FERRANTE
Regulation Number862.1113
Classification Product Code
MQM  
Date Received05/16/2002
Decision Date 04/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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