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 Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
510(k) Number K896032
Device Name MODIFIED ELISA FOR CHLAMYDIA
Applicant
Fairleigh Dickinson Laboratories, Inc.
1249 Ambler Ave.
Abilene,  TX  79601
Applicant Contact C MANSFIELD
Correspondent
Fairleigh Dickinson Laboratories, Inc.
1249 Ambler Ave.
Abilene,  TX  79601
Correspondent Contact C MANSFIELD
Regulation Number866.3120
Classification Product Code
LJC  
Date Received10/16/1989
Decision Date 01/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-