LUMINEX LX 100/200 INSTRUMENT


Device Classification Name

instrumentation for clinical multiplex test systems

510(k) Number K073506
Device Name LUMINEX LX 100/200 INSTRUMENT
Applicant
LUMINEX CORP.
439 university avenue suite
2000
toronto, 

CA

m5g 1y8

Applicant Contact nancy krunic
Correspondent
LUMINEX CORP.
439 university avenue suite
2000
toronto, 

CA

m5g 1y8

Correspodent Contact nancy krunic
Regulation Number 862.2570
Classification Product Code
NSU  
Date Received 12/13/2007
Decision Date 03/07/2008
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