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 K873668
Device Name MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
Applicant
Medix Biotech, Inc.
420 Lincoln Centre Dr.
Foster City,  CA  94404
Applicant Contact JOHN J HUANG
Correspondent
Medix Biotech, Inc.
420 Lincoln Centre Dr.
Foster City,  CA  94404
Correspondent Contact JOHN J HUANG
Regulation Number862.1485
Classification Product Code
CEP  
Date Received09/10/1987
Decision Date 10/07/1987
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
-
-