SPECTRAL’S CARDIAC STATUS CK-MB RAPID TEST


Device Classification Name

chromatographic separation, cpk isoenzymes

510(k) Number K022409
Device Name SPECTRAL’S CARDIAC STATUS CK-MB RAPID TEST
Original Applicant
SPECTRAL DIAGNOSTICS, INC.
135-2 the west mall
toronto, ontario, 

CA

m9c1c2

Original Contact nisar a shaikh
Regulation Number 862.1215
Classification Product Code
JHT  
Date Received 07/24/2002
Decision Date 09/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No