Cleared Traditional

K022409 - SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
(FDA 510(k) Clearance)

K022409 · Spectral Diagnostics, Inc. · Chemistry

Sep 2002

Decision

68d

Days

Class 2

Risk

K022409 is an FDA 510(k) clearance for the SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST, a Chromatographic Separation, Cpk Isoenzymes (Class II — Special Controls, product code JHT), submitted by Spectral Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on September 30, 2002, 68 days after receiving the submission on July 24, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number	K022409 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2002
Decision Date	September 30, 2002
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement