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510(k) K893662

J&S IRON SATURATING REAGENTS by J.S. Medical Assoc. — Product Code JMO

K893662 is an FDA 510(k) premarket notification submitted by J.S. Medical Assoc. for the device "J&S IRON SATURATING REAGENTS". The FDA issued a decision of Substantially Equivalent on July 20, 1989. The device falls under product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. J.S. Medical Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1989
Date Received
May 15, 1989
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 J.S. Medical Assoc.

  • K932752 — VISI-SPOT (November 5, 1993)
  • K932688 — EYE SPOT IM TEST (September 8, 1993)
  • K932180 — EYE SPOT CRP TEST (August 23, 1993)
  • K932551 — ACCUTEX IM LATEX TEST (August 9, 1993)
  • K926112 — ACCUTEX BETA-HCG TEST (July 28, 1993)
  • K924332 — ACCUTEX CRP LATEX TEST (December 7, 1992)
  • K924247 — ACCUTEX ASO LATEX TEST (December 7, 1992)
  • K924036 — ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST (December 1, 1992)
  • K924248 — ACCUTEX SLE LATEX TEST (November 2, 1992)
  • K924037 — ACCUTEX IM RBC TEST (November 2, 1992)

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)
  • K994115 — TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE (January 28, 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)

FDA data resources