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510(k) K983134

NBIL by Abbott Laboratories — Product Code MQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1998
Date Received
September 8, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bilirubin (Total And Unbound) In The Neonate Test System
Device Class
Class I
Regulation Number
862.1113
Review Panel
CH
Submission Type

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