• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name calibrator, multi-analyte mixture
510(k) Number K011035
Device Name DIMENSION DRUG CALIBRATOR, MODEL DC22B
Original Applicant
DADE BEHRING, INC.
glasgow business community
bldg 500, ms 514 p.o.box 6101
newark,  DE  19714 6101
Original Contact richard m vaught
Regulation Number862.1150
Classification Product Code
JIX  
Date Received04/05/2001
Decision Date 06/14/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-