Home / 510(k) Clearances / K032012

510(k) K032012

HOMOCYSTEINE MICROTITER PLATE ASSAY by Diazyme Laboratories — Product Code LPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2003
Date Received
June 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinary Homocystine (Nonquantitative) Test System
Device Class
Class II
Regulation Number
862.1377
Review Panel
CH
Submission Type

Other clearances by Diazyme Laboratories

  • K253358 — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Li (December 19, 2025)
  • K243462 — Diazyme Colorimetric Lithium Assay (August 1, 2025)
  • K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai (September 8, 2022)
  • K220001 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai (August 4, 2022)
  • K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemilu (December 13, 2021)
  • K203136 — Diazyme PLAC® Test for Lp-PLA2 Activity (August 6, 2021)
  • K180209 — Diazyme 1,5-AG Assay (October 4, 2018)
  • K181438 — Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chai (June 26, 2018)
  • K180074 — Diazyme Lipoprotein (a) Assay (March 22, 2018)
  • K172992 — Diazyme EZ Vitamin D Assay (January 11, 2018)

Other clearances for product code LPS

  • K123930 — VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VE (May 15, 2013)
  • K121053 — DIAZYME HOMOCYSTEINE POC TEST KIT (July 31, 2012)
  • K121533 — ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMO (June 15, 2012)
  • K113793 — HOMOCYSTEINE TEST (June 5, 2012)
  • K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (May 7, 2012)
  • K083222 — AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 (July 31, 2009)
  • K080851 — A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY (October 10, 2008)
  • K073640 — ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS (April 24, 2008)
  • K071971 — DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZ (September 17, 2007)
  • K063701 — TECO HOMOCYSTEINE ENZYMATIC ASSAY (April 11, 2007)