SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST


Device Classification Name

immunoassay method, troponin subunit

510(k) Number K030057
Device Name SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 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
MMI  
Subsequent Product Codes
DDR   JHT  
Date Received 01/07/2003
Decision Date 03/19/2003
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