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510(k) K052082

FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 by Beckman Coulter, Inc. — Product Code JMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2005
Date Received
August 2, 2005
Clearance Type
Special
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

  • K234052 — Access Ferritin (March 20, 2024)
  • 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)
  • K926221 — ACCESS FERRITIN ASSAY (January 13, 1993)
  • K925848 — IMMULITE FERRITIN (January 13, 1993)
  • K920829 — COBAS CORE FERRITIN EIA (June 19, 1992)
  • K920318 — CEDIA FERRITIN ASSAY (June 4, 1992)
  • K902997 — MILENIA (TM) FERRITIN (August 2, 1990)