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 Calibrator, Primary
510(k) Number K951629
Device Name IMX ESTRADIOL
Applicant
Abbott Laboratories
Dept 49c, Bldg. Ap31
200 Abbott Rd.
Abbott Park,  IL  60064
Applicant Contact JOY C SONSALLA
Correspondent
Abbott Laboratories
Dept 49c, Bldg. Ap31
200 Abbott Rd.
Abbott Park,  IL  60064
Correspondent Contact JOY C SONSALLA
Regulation Number862.1150
Classification Product Code
JIS  
Subsequent Product Code
CHP  
Date Received03/17/1995
Decision Date 05/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-