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510(k) K955797

IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR by Randox Laboratories, Ltd. — Product Code DFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1996
Date Received
December 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

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