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510(k) K073640

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS by Axis-Shield Diagnostics, Ltd. — Product Code LPS

K073640 is an FDA 510(k) premarket notification submitted by Axis-Shield Diagnostics, Ltd. for the device "ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS". The FDA issued a decision of Substantially Equivalent on April 24, 2008. The device falls under product code LPS (Urinary Homocystine (Nonquantitative) Test System), a Class II device regulated under 21 CFR 862.1377. Axis-Shield Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2008
Date Received
December 26, 2007
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

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  • K241176 — Alere NT-proBNP for Alinity i Reagent Kit (January 16, 2025)
  • K233541 — ARCHITECT Active-B12 (Holotranscobalamin) (July 31, 2024)
  • K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (October 27, 2017)
  • K121946 — AXIS-SHIELD ACVTIVE-B12 (March 22, 2013)
  • K121842 — ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C (December 12, 2012)
  • K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (May 7, 2012)
  • K112443 — ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) (December 19, 2011)
  • K110296 — AXIS-SHIELD ANTI-CCP (August 18, 2011)
  • K083868 — ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P (September 25, 2009)

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)
  • K071971 — DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZ (September 17, 2007)
  • K063701 — TECO HOMOCYSTEINE ENZYMATIC ASSAY (April 11, 2007)
  • K063206 — DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CON (December 28, 2006)

FDA data resources