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 Test, Natriuretic Peptide
510(k) Number K082645
Device Name DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623
Applicant
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714
Applicant Contact VICTOR M CARRIO
Correspondent
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714
Correspondent Contact VICTOR M CARRIO
Regulation Number862.1117
Classification Product Code
NBC  
Date Received09/11/2008
Decision Date 09/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-