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510(k) K840213

BLOOD UREA NITROGEN REAGENT SYS by Sclavo, Inc. — Product Code JGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1984
Date Received
January 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
O-Phthalaldehyde, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

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