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510(k) K863327

IMMPULSE IGE ASSAY REAGENTS by Sclavo, Inc. — Product Code DGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1986
Date Received
August 27, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ige, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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