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510(k) K902877

TOTAL IRON FOR MANUAL/AUTOMATED by Catachem, Inc. — Product Code JIY

K902877 is an FDA 510(k) premarket notification submitted by Catachem, Inc. for the device "TOTAL IRON FOR MANUAL/AUTOMATED". The FDA issued a decision of Substantially Equivalent on July 27, 1990. The device falls under product code JIY (Photometric Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Catachem, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1990
Date Received
July 2, 1990
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

Other clearances by Catachem, Inc.

  • K062503 — CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT (January 19, 2007)
  • K945408 — 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER (February 22, 1995)
  • K932871 — UIBC FOR DISCREET RANDOM ACCESS ANALYZER (September 8, 1993)
  • K903341 — MAGNESIUM (August 22, 1990)
  • K902326 — AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS (July 31, 1990)
  • K895748 — BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS (December 21, 1989)
  • K895821 — URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS (December 5, 1989)
  • K894715 — CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS (November 8, 1989)
  • K894476 — CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION (October 12, 1989)
  • K894389 — CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS (October 12, 1989)

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)
  • K981241 — IRON (May 1, 1998)
  • K973933 — SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 (November 4, 1997)
  • K972363 — IL TEST IRON (August 15, 1997)

FDA data resources