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510(k) K840460

CORNINGS MAGIC FERRITIN RADIOIMMUNO- by Corning Medical & Scientific — Product Code JMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1984
Date Received
February 2, 1984
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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  • K950393 — ACE(TM) CEDIA(R) FERRITIN ASSAY (May 16, 1995)
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  • K926221 — ACCESS FERRITIN ASSAY (January 13, 1993)
  • K920829 — COBAS CORE FERRITIN EIA (June 19, 1992)
  • K920318 — CEDIA FERRITIN ASSAY (June 4, 1992)