• 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 multi-analyte controls, all kinds (assayed)
510(k) Number K925256
Device Name QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL
Original Applicant
QUANTIMETRIX CORP.
4955 west 145 st.
hawthorne,  CA  90250 6703
Original Contact john p tarburton
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/19/1992
Decision Date 03/01/1993
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-