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510(k) K890573

KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT by Kenlor Industries, Inc. — Product Code JIY

K890573 is an FDA 510(k) premarket notification submitted by Kenlor Industries, Inc. for the device "KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT". The FDA issued a decision of Substantially Equivalent on Mar 24, 1989. The device falls under product code JIY (Photometric Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Kenlor Industries, Inc. has 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 24, 1989
Date Received
Feb 6, 1989
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
510(k) Exempt

Other clearances by Kenlor Industries, Inc.

  • K964014 — KENLOR H. PYLORI CONTROL SERUM (Mar 3, 1997)
  • K952840 — KENLOR LIQUID TOTAL URINE CONTROL (Jul 19, 1995)
  • K950326 — KENLOR HUMAN SPINAL FLUID CONTROL (Mar 20, 1995)
  • K903338 — KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL (Sep 7, 1990)
  • K896440 — KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT (Feb 16, 1990)
  • K890618 — COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT (May 22, 1989)
  • K890576 — KENLOR HUMAN SPINAL FLUID CONTROL LIQUID (Mar 9, 1989)
  • K890577 — KENLOR LIQUID URINE CONTROL (Mar 9, 1989)

Other clearances for product code JIY

  • K061793 — DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR (Aug 7, 2006)
  • K060264 — DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) (Mar 8, 2006)
  • K051115 — SENTINEL IRON LIQUID (Aug 25, 2005)
  • K033983 — VITALAB IRON REAGENT (May 21, 2004)
  • K030528 — ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) (Jun 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 (Nov 13, 2001)
  • K981241 — IRON (May 1, 1998)
  • K973933 — SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 (Nov 4, 1997)
  • K972363 — IL TEST IRON (Aug 15, 1997)

FDA data resources

Source: FDA 510(k) database entry for K890573. Report a data issue: hello@regdatalab.com.