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510(k) K964913

IRON REAGENT by Derma Media Lab., Inc. — Product Code JIY

K964913 is an FDA 510(k) premarket notification submitted by Derma Media Lab., Inc. for the device "IRON REAGENT". The FDA issued a decision of Substantially Equivalent on February 20, 1997. The device falls under product code JIY (Photometric Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Derma Media Lab., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1997
Date Received
December 9, 1996
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 Derma Media Lab., Inc.

  • K970664 — GLUCOSE REAGENT (August 1, 1997)
  • K971309 — UREA (August 1, 1997)
  • K971072 — CHOLESTEROL REAGENT (June 20, 1997)
  • K971005 — TRIGLYCERIDES (April 21, 1997)
  • K970867 — URIC ACID REAGENT (April 21, 1997)
  • K964915 — MAGNESIUM (March 26, 1997)
  • K965134 — ALT/SGPT (February 18, 1997)
  • K964914 — ALKALINE PHOSPHATASE (February 4, 1997)
  • K965126 — AST/SGOT (January 17, 1997)
  • K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE (January 10, 1997)

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