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, luteinizing hormone
510(k) Number K871332
Device Name CLEARPLAN
Applicant
UNIPATH LTD.
NORSE ROAD
BEDFORD MK41 OQG,  GB
Applicant Contact GEORGE ZAJICEK
Correspondent
UNIPATH LTD.
NORSE ROAD
BEDFORD MK41 OQG,  GB
Correspondent Contact GEORGE ZAJICEK
Regulation Number862.1485
Classification Product Code
CEP  
Date Received04/03/1987
Decision Date 08/05/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-