A/C ENZYMATIC HOMOCYSTEINE ASSAY— 510(k) K030754

Name: FDA 510(k) clearance K030754
Creator: U.S. Food and Drug Administration
Published: 2003-07-11

Substantially Equivalent

Anticancer, Inc.

FDA 510(k) clearance K030754 for A/C ENZYMATIC HOMOCYSTEINE ASSAY, Substantially Equivalent on 2003-07-11. 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: 2003-03-10
Decision date: 2003-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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