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510(k) K912795

BIOTROL UIBC REAGENT by Biotrol, USA, Inc. — Product Code JMO

K912795 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL UIBC REAGENT". The FDA issued a decision of Substantially Equivalent on August 12, 1991. The device falls under product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1991
Date Received
June 25, 1991
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 Biotrol, USA, Inc.

  • K934014 — VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT (December 6, 1995)
  • K931141 — BIOTROL AMYLASE CNPG3 (May 26, 1993)
  • K921855 — BIOTROL BICARBONATE STANDARDS (August 3, 1992)
  • K921677 — BIOTROL MAGNESIUM (MAGON) (May 26, 1992)
  • K910721 — BIOTROL PROTEIN MULTILEVEL STANDARDS (May 6, 1991)
  • K905683 — BIOTROL LACTATE DEHYDROGENASE (L-P) (March 11, 1991)
  • K905280 — BIOTROL BILIRUBIN C & T CONTROL (February 4, 1991)
  • K894544 — BIOTROL RUB-E.I.A. TEST G (August 30, 1989)
  • K891061 — BIOTROL CALCIUM MONOREACTIF (August 10, 1989)
  • K891286 — BIOTROL CHEMISTRY URINE CONTROL (April 10, 1989)

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