TC MATRIX CLINICAL CHEMISTRY ANALYZER


Device Classification Name

analyzer, chemistry (photometric, discrete), for clinical use

510(k) Number K073370
Device Name TC MATRIX CLINICAL CHEMISTRY ANALYZER
Applicant
TECO DIAGNOSTICS
1268 north lakeview ave.
anaheim, 
CA 
92807

Applicant Contact jim vaechhes
Correspondent
TECO DIAGNOSTICS
1268 north lakeview ave.
anaheim, 
CA 
92807

Correspodent Contact jim vaechhes
Regulation Number 862.2160
Classification Product Code
JJE  
Subsequent Product Codes
CDQ   CGA   CIX   CKA   JIX  
Date Received 11/30/2007
Decision Date 05/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No