Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name acid, lactic, enzymatic method
510(k) Number K113216
Device Name RAPIDPOINT 500 BLOOD GAS ANALYER
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
2 EDGEWATER DRIVE
NORWOOD,  MA  02062
Applicant Contact Steven Goldberg
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
2 EDGEWATER DRIVE
NORWOOD,  MA  02062
Correspondent Contact Steven Goldberg
Regulation Number862.1450
Classification Product Code
KHP  
Date Received11/01/2011
Decision Date 05/03/2012
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
Recalls CDRH Recalls
-
-