DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR


Device Classification Name

alpha-naphthyl phosphate, alkaline phosphatase or isoenzymes

510(k) Number K121907
Device Name DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
p.o. box 6101, mailstap 514
newark, 
DE 
19714

Applicant Contact rose t marinelli
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
p.o. box 6101, mailstap 514
newark, 
DE 
19714

Correspodent Contact rose t marinelli
Regulation Number 862.1050
Classification Product Code
CJO  
Subsequent Product Code
JIT  
Date Received 06/29/2012
Decision Date 07/23/2012
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