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510(k) K981241

IRON by Abbott Laboratories — Product Code JIY

K981241 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "IRON". The FDA issued a decision of Substantially Equivalent on May 1, 1998. The device falls under product code JIY (Photometric Method, 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
May 1, 1998
Date Received
April 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, 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 JIY

  • K061793 — DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR (August 7, 2006)
  • K060264 — DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) (March 8, 2006)
  • K051115 — SENTINEL IRON LIQUID (August 25, 2005)
  • K033983 — VITALAB IRON REAGENT (May 21, 2004)
  • K030528 — ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) (June 17, 2003)
  • K020816 — IRON-PC-SL ASSAY MODEL # 151-10, 151-26 (May 14, 2002)
  • K013097 — WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 (November 13, 2001)
  • K973933 — SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 (November 4, 1997)
  • K972363 — IL TEST IRON (August 15, 1997)
  • K964913 — IRON REAGENT (February 20, 1997)

FDA data resources