CARDIOQUANT TROPONIN I TEST


Device Classification Name

immunoassay method, troponin subunit

510(k) Number K992127
Device Name CARDIOQUANT TROPONIN I TEST
Applicant
SPECTRAL DIAGNOSTICS, INC.
5550 n.w. 102 place
miami, 
FL 
33178

Applicant Contact francee s boches
Correspondent
SPECTRAL DIAGNOSTICS, INC.
5550 n.w. 102 place
miami, 
FL 
33178

Correspodent Contact francee s boches
Regulation Number 862.1215
Classification Product Code
MMI  
Date Received 06/23/1999
Decision Date 10/04/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No