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510(k) K935176

IRON TEST by Em Diagnostic Systems, Inc. — Product Code JIY

K935176 is an FDA 510(k) premarket notification submitted by Em Diagnostic Systems, Inc. for the device "IRON TEST". The FDA issued a decision of Substantially Equivalent on December 16, 1993. The device falls under product code JIY (Photometric Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Em Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1993
Date Received
October 27, 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 Em Diagnostic Systems, Inc.

  • K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST (January 27, 1994)
  • K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST (January 13, 1994)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935183 — EMDS MAGNESIUM (MG) TEST (December 9, 1993)
  • K935182 — EMDS ALKANINE PHOSPHATASE (ALP) TEST (December 9, 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