DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI


Device Classification Name

alpha-naphthyl phosphate, alkaline phosphatase or isoenzymes

510(k) Number K122323
Device Name DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 gbc drive
ms 514
newark, 
DE 
19702

Applicant Contact rose t marinelli
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
500 gbc drive
ms 514
newark, 
DE 
19702

Correspodent Contact rose t marinelli
Regulation Number 862.1050
Classification Product Code
CJO  
Subsequent Product Code
JIT  
Date Received 08/01/2012
Decision Date 08/28/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No