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510(k) K994115

TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE by Dade Behring, Inc. — Product Code JMO

K994115 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on January 28, 2000. The device falls under product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2000
Date Received
December 6, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ferrozine (Colorimetric) Iron Binding Capacity
Device Class
Class I
Regulation Number
862.1415
Review Panel
CH
Submission Type

Other clearances by Dade Behring, Inc.

  • K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT07 (December 20, 2010)
  • K081161 — DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI (July 28, 2008)
  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (June 25, 2008)
  • K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (June 4, 2008)
  • K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CAR (March 13, 2008)
  • K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA (February 26, 2008)
  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
  • K073055 — DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (January 3, 2008)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code JMO

  • K113438 — ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, AC (June 1, 2012)
  • K061464 — VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 (June 15, 2006)
  • K052867 — VITROS CHEMISTRY PRODUCTS DTIBC REAGENT (December 23, 2005)
  • K041793 — OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 (July 16, 2004)
  • K013102 — WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492 (November 13, 2001)
  • K012340 — BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) (October 1, 2001)
  • K000781 — DIRECT TIBC KIT (May 2, 2000)
  • K991666 — TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (June 30, 1999)
  • K991244 — TOTAL IRON, MODELS FE 109-01, FE 109-02 (May 25, 1999)
  • K990216 — MAGNETIC TIBC KIT (February 16, 1999)

FDA data resources