MODIFICATION TO IMX HOMOCYSTEINE— 510(k) K992274

Name: FDA 510(k) clearance K992274
Creator: U.S. Food and Drug Administration
Published: 1999-10-06

Substantially Equivalent

Axis Biochemicals, Asa

FDA 510(k) clearance K992274 for MODIFICATION TO IMX HOMOCYSTEINE, Substantially Equivalent on 1999-10-06. Applicant: Axis Biochemicals, Asa. Device class: 2.

Clearance details

Applicant: Axis Biochemicals, Asa
Product code: Code LPS
Device class: Class 2
Regulation: 21 CFR 862.1377
Advisory panel: Clinical Chemistry
Date received: 1999-07-06
Decision date: 1999-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LPS

view all

K123930 — VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III2013-05-15
K121053 — DIAZYME HOMOCYSTEINE POC TEST KIT2012-07-31
K121533 — ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET2012-06-15
K113793 — HOMOCYSTEINE TEST2012-06-05
K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON2012-05-07

More clearances from Axis Biochemicals, Asa

view all

K980907 — AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY1998-10-16
K980812 — IMX HOMOCYSTEINE1998-10-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.