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510(k) K920318

CEDIA FERRITIN ASSAY by Microgenics Corp. — Product Code JMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1992
Date Received
January 24, 1992
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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Other clearances for product code JMG

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  • K964282 — TINA-QUANT FERRITIN ASSAY (July 30, 1997)
  • K971833 — ELECSYS FERRITIN (June 2, 1997)
  • K963498 — FERR FLEX REAGENT CARTRIDGE (January 24, 1997)
  • K950393 — ACE(TM) CEDIA(R) FERRITIN ASSAY (May 16, 1995)
  • K925848 — IMMULITE FERRITIN (January 13, 1993)
  • K926221 — ACCESS FERRITIN ASSAY (January 13, 1993)
  • K920829 — COBAS CORE FERRITIN EIA (June 19, 1992)
  • K902997 — MILENIA (TM) FERRITIN (August 2, 1990)