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510(k) K991244

TOTAL IRON, MODELS FE 109-01, FE 109-02 by A.P. Total Care, Inc. — Product Code JMO

K991244 is an FDA 510(k) premarket notification submitted by A.P. Total Care, Inc. for the device "TOTAL IRON, MODELS FE 109-01, FE 109-02". The FDA issued a decision of Substantially Equivalent on May 25, 1999. The device falls under product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. A.P. Total Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1999
Date Received
April 12, 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 A.P. Total Care, Inc.

  • K991246 — FRUCTOSAMINE, MODEL FR 106-01 (December 16, 1999)
  • K991762 — ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 (September 2, 1999)
  • K991761 — MAGNESIUM PRODUCT NO'S, 112-01, 112-02 (September 2, 1999)
  • K991664 — LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 (August 19, 1999)
  • K991665 — HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 (August 10, 1999)
  • K991866 — BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 (August 2, 1999)
  • K991867 — INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (August 2, 1999)
  • K991870 — ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 (July 30, 1999)
  • K991666 — TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (June 30, 1999)
  • K991663 — AST/SGOT (June 30, 1999)

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)
  • K990216 — MAGNETIC TIBC KIT (February 16, 1999)

FDA data resources