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510(k) K935712

IRON/TIBC REAGENT by Horizon Diagnostics, Inc. — Product Code JIY

K935712 is an FDA 510(k) premarket notification submitted by Horizon Diagnostics, Inc. for the device "IRON/TIBC REAGENT". The FDA issued a decision of Substantially Equivalent on September 20, 1995. The device falls under product code JIY (Photometric Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Horizon Diagnostics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1995
Date Received
November 30, 1993
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 Horizon Diagnostics, Inc.

  • K971566 — CREATINE KINASE-MB REAGENT SET (July 14, 1997)
  • K933722 — HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT (June 13, 1996)
  • K930678 — AMYLASE (April 6, 1994)
  • K934533 — BUN-300/BUN-500 UREA NITROGEN REAGENT (November 26, 1993)
  • K930679 — DIRECT BILIRUBIN (June 29, 1993)
  • K930074 — IN-VITRO DIAGNOSTIC REAGENT SET (May 11, 1993)

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