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, Prolactin (Lactogen)
510(k) Number K861271
Device Name SUCROSEP HUMAN PROLACTIN (HPR) IRMA
Applicant
Boots-Celltech Diagnostics, Inc.
240 Bath Rd.
Slough Sl1 4et
Berkshire, England,  GB
Applicant Contact JOHN G SIMPSON
Correspondent
Boots-Celltech Diagnostics, Inc.
240 Bath Rd.
Slough Sl1 4et
Berkshire, England,  GB
Correspondent Contact JOHN G SIMPSON
Regulation Number862.1625
Classification Product Code
CFT  
Date Received04/04/1986
Decision Date 06/27/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-