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 Radioimmunoassay, Progesterone
510(k) Number K873431
Device Name PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH
Applicant
Serono Diagnostics, Inc.
100 Longwater Circle
Norwell,  MA  02061
Applicant Contact PHILIP M FANTASIA
Correspondent
Serono Diagnostics, Inc.
100 Longwater Circle
Norwell,  MA  02061
Correspondent Contact PHILIP M FANTASIA
Regulation Number862.1620
Classification Product Code
JLS  
Date Received08/26/1987
Decision Date 10/20/1987
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
-
-