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FDA 510(k) Application Details - K021622
Device Classification Name
Bilirubin (Total And Unbound) In The Neonate Test System
More FDA Info for this Device
510(K) Number
K021622
Device Name
Bilirubin (Total And Unbound) In The Neonate Test System
Applicant
HILL-ROM AIR-SHIELDS
330 JACKSONVILLE RD.
HATBORO, PA 19040 US
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Contact
MONICA FERRANTE
Other 510(k) Applications for this Contact
Regulation Number
862.1113
More FDA Info for this Regulation Number
Classification Product Code
MQM
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More FDA Info for this Product Code
Date Received
05/16/2002
Decision Date
04/01/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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