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510(k) K960485

SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS by Beckman Instruments, Inc. — Product Code JMO

K960485 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS". The FDA issued a decision of Substantially Equivalent on May 10, 1996. The device falls under product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Beckman Instruments, Inc. has 280 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1996
Date Received
Feb 2, 1996
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
510(k) Exempt

Other clearances by Beckman Instruments, Inc.

  • K973448 — ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460… (Sep 17, 1998)
  • K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (Jul 14, 1998)
  • K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT (May 8, 1998)
  • K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (May 1, 1998)
  • K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 (Mar 18, 1998)
  • K974816 — ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (Feb 20, 1998)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (Feb 17, 1998)
  • K974110 — IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (Dec 24, 1997)
  • K974452 — VIGIL LIPID CONTROL (Dec 17, 1997)
  • K973932 — BECKMAN CALIBRATOR 2 (CAL2) (Dec 15, 1997)

Other clearances for product code JMO

  • K113438 — ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT… (Jun 1, 2012)
  • K061464 — VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120… (Jun 15, 2006)
  • K052867 — VITROS CHEMISTRY PRODUCTS DTIBC REAGENT (Dec 23, 2005)
  • K041793 — OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 (Jul 16, 2004)
  • K013102 — WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT… (Nov 13, 2001)
  • K012340 — BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) (Oct 1, 2001)
  • K000781 — DIRECT TIBC KIT (May 2, 2000)
  • K994115 — TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE (Jan 28, 2000)
  • K991666 — TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (Jun 30, 1999)
  • K991244 — TOTAL IRON, MODELS FE 109-01, FE 109-02 (May 25, 1999)

FDA data resources

Source: FDA 510(k) database entry for K960485. Report a data issue: hello@regdatalab.com.