• 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 immunoabsorption assay, treponema pallidum
510(k) Number K900654
Device Name MODIFIED CAPTIA(R) SYPHILIS-M
Applicant
MERCIA DIAGNOSTICS LTD.
MERCIA HOUSEET
BROADFORD PARK
GUILDFORD, SURREY ENGLAND,  GB GU4 8EW
Applicant Contact LEWIS, PHD
Correspondent
MERCIA DIAGNOSTICS LTD.
MERCIA HOUSEET
BROADFORD PARK
GUILDFORD, SURREY ENGLAND,  GB GU4 8EW
Correspondent Contact LEWIS, PHD
Regulation Number866.3830
Classification Product Code
LIP  
Date Received02/09/1990
Decision Date 03/08/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-