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510(k) K890697

RIA-GNOST FERRITIN by Cambridge Medical Technology — Product Code JMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1989
Date Received
February 10, 1989
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

Other clearances by Cambridge Medical Technology

  • K890837 — RIA-GNOST INSULIN (April 26, 1989)
  • K890836 — RIA-GNOST PROGESTERONE (March 16, 1989)
  • K873737 — NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY (November 24, 1987)
  • K870573 — T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT (April 22, 1987)
  • K862871 — RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL (August 19, 1986)
  • K860130 — TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT (February 19, 1986)
  • K855169 — T3 UPTAKE RADIOIMMUNOASSAY KIT (February 6, 1986)
  • K850254 — PARATHYROID HORMONE RADIOIMMUNOASSAY KIT (April 3, 1985)
  • K843635 — MATCHED COMPONENT SET FOR RADIOIMMUNO- (September 28, 1984)
  • K841042 — MATCHED COMPONENT SET RADIOIMMUNOASSAY (April 19, 1984)

Other clearances for product code JMG

  • K234052 — Access Ferritin (March 20, 2024)
  • K052082 — FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 (August 19, 2005)
  • 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)
  • K920318 — CEDIA FERRITIN ASSAY (June 4, 1992)