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 Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K864319
Device Name TDX(R) II ANALYZER
Applicant
ABBOTT LABORATORIES
1921 HURD DR.
P.O.BOX 152020
IRVING,  TX  75015 -2020
Applicant Contact KEITH MINTER
Correspondent
ABBOTT LABORATORIES
1921 HURD DR.
P.O.BOX 152020
IRVING,  TX  75015 -2020
Correspondent Contact KEITH MINTER
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received11/03/1986
Decision Date 12/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-