Home / 510(k) Clearances / K926221

510(k) K926221

ACCESS FERRITIN ASSAY by Bio-Rad Laboratories, Inc. — Product Code JMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1993
Date Received
December 10, 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

Other clearances by Bio-Rad Laboratories, Inc.

  • K183446 — BioPlex 2200 Lyme Total (March 12, 2019)
  • K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (February 13, 2019)
  • K180577 — BioPlex 2200 25-OH Vitamin D Kit (June 22, 2018)
  • K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview So (September 13, 2017)
  • K170509 — BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC I (May 19, 2017)
  • K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator (May 11, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K161687 — D-10 Hemoglobin A1c Program (October 14, 2016)
  • K152679 — Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, (May 10, 2016)
  • DEN150058 — Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 (March 28, 2016)

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)
  • K920829 — COBAS CORE FERRITIN EIA (June 19, 1992)
  • K920318 — CEDIA FERRITIN ASSAY (June 4, 1992)
  • K902997 — MILENIA (TM) FERRITIN (August 2, 1990)