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510(k) K840485

TOTAL IRON UIBC/TIBC ASSAY by Somas Medical Industries, Inc. — Product Code CFM

K840485 is an FDA 510(k) premarket notification submitted by Somas Medical Industries, Inc. for the device "TOTAL IRON UIBC/TIBC ASSAY". The FDA issued a decision of Substantially Equivalent on March 12, 1984. The device falls under product code CFM (Bathophenanthroline, Colorimetry, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Somas Medical Industries, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1984
Date Received
February 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bathophenanthroline, Colorimetry, Iron (Non-Heme)
Device Class
Class I
Regulation Number
862.1410
Review Panel
CH
Submission Type

Other clearances by Somas Medical Industries, Inc.

  • K862179 — SOMAS LIQUID URINE CONTROL (July 1, 1986)
  • K842134 — SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY (July 6, 1984)
  • K840486 — TOTAL BILIRUBIN REAGENT (April 25, 1984)
  • K840974 — SOMAS HUMAN SPINAL FLUID CONTROL (April 5, 1984)
  • K833787 — SOMAS CHLORIDE ASSAY KIT (January 11, 1984)

Other clearances for product code CFM

  • K984119 — WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR (January 15, 1999)
  • K981581 — IRON (June 8, 1998)
  • K932871 — UIBC FOR DISCREET RANDOM ACCESS ANALYZER (September 8, 1993)
  • K913705 — ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 (October 9, 1991)
  • K912912 — SYNERMED SERUM IRON-600 REAGENT KIT (July 30, 1991)
  • K902918 — SYNERMED SERUM IRON REAGENT KIT (July 31, 1990)
  • K895047 — CLINISTAT POTASSIUM REAGENT TEST (October 17, 1989)
  • K891155 — IRON REAGENT (April 18, 1989)
  • K873120 — ABBOTT A-GENT IRON REAGENT KIT (August 25, 1987)
  • K861602 — TOTAL IRON BINDING CAPACITY PROCEDURE (May 23, 1986)

FDA data resources