Cleared Traditional

K040880 - MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
(FDA 510(k) Clearance)

K040880 · Medical Analysis Systems, Inc. · Chemistry

Apr 2004

Decision

23d

Days

Class 1

Risk

K040880 is an FDA 510(k) clearance for the MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY).

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on April 28, 2004, 23 days after receiving the submission on April 5, 2004.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K040880 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 2004
Decision Date	April 28, 2004
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement