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 K850480
Device Name OVU STICK SELF-TEST -MODIFICATION
Applicant
Monoclonal Antibodies, Inc.
2319 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact MICHAEL C MALONEY
Correspondent
Monoclonal Antibodies, Inc.
2319 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact MICHAEL C MALONEY
Regulation Number862.1485
Classification Product Code
CEP  
Date Received01/30/1985
Decision Date 03/05/1985
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
-
-