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 K880933
Device Name AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST
Applicant
AMERSHAM CORP.
2636 SOUTH CLEARBROOK DR.
ARLINGTON HEIGHTS,  IL  60005
Applicant Contact JAN L ZORN
Correspondent
AMERSHAM CORP.
2636 SOUTH CLEARBROOK DR.
ARLINGTON HEIGHTS,  IL  60005
Correspondent Contact JAN L ZORN
Regulation Number862.1485
Classification Product Code
CEP  
Date Received03/07/1988
Decision Date 07/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-