STA(R) – LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH


Device Classification Name

assay, heparin

510(k) Number K111822
Device Name STA(R) – LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
Applicant
DIAGNOSTICA STAGO, INC.
piazza albania, 10
rome, 

IT

00153

Applicant Contact carlo d’alessandro
Correspondent
DIAGNOSTICA STAGO, INC.
piazza albania, 10
rome, 

IT

00153

Correspodent Contact carlo d’alessandro
Regulation Number 864.7525
Classification Product Code
KFF  
Subsequent Product Codes
GGN   JIS  
Date Received 06/28/2011
Decision Date 10/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls