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510(k) K801300

DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) by E.I. Dupont DE Nemours & Co., Inc. — Product Code JIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1980
Date Received
June 2, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Surrogate
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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