A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY— 510(k) K080851

Name: FDA 510(k) clearance K080851
Creator: U.S. Food and Drug Administration
Published: 2008-10-10

Substantially Equivalent

Anticancer, Inc.

FDA 510(k) clearance K080851 for A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY, Substantially Equivalent on 2008-10-10. Applicant: Anticancer, Inc.. Device class: 2.

Clearance details

Applicant: Anticancer, Inc.
Product code: Code LPS
Device class: Class 2
Regulation: 21 CFR 862.1377
Advisory panel: Clinical Chemistry
Date received: 2008-03-26
Decision date: 2008-10-10
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 Anticancer, Inc.

view all

K111260 — A/C ENZYMATIC VITAMIN B6 ASSAY2012-07-26
K030754 — A/C ENZYMATIC HOMOCYSTEINE ASSAY2003-07-11

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