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510(k) K963498

FERR FLEX REAGENT CARTRIDGE by Dade Chemistry Systems, Inc. — Product Code JMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1997
Date Received
September 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay (Two-Site Solid Phase), Ferritin
Device Class
Class II
Regulation Number
866.5340
Review Panel
CH
Submission Type

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