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510(k) K842505

TDX REA IRON DIAGNOSTIC KIT by Abbott Laboratories — Product Code CFM

K842505 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX REA IRON DIAGNOSTIC KIT". The FDA issued a decision of Substantially Equivalent on August 7, 1984. The device falls under product code CFM (Bathophenanthroline, Colorimetry, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1984
Date Received
June 26, 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

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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