DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56


Device Classification Name

calibrator, secondary

510(k) Number K081319
Device Name DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
Applicant
Siemens Healthcare Diagnostics Inc.
500 gbc drive
ms 514
newark, 
DE 
19702

Applicant Contact george m plummer
Correspondent
Siemens Healthcare Diagnostics Inc.
500 gbc drive
ms 514
newark, 
DE 
19702

Correspodent Contact george m plummer
Regulation Number 862.1150
Classification Product Code
JIT  
Date Received 05/12/2008
Decision Date 08/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No