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 Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K914853
Device Name ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT
Applicant
Reads Medical Products, Inc.
Tejon St. Suite 120
Metro Tech Centre
Westminster,  CO  80234
Applicant Contact DEBRA SONGER
Correspondent
Reads Medical Products, Inc.
Tejon St. Suite 120
Metro Tech Centre
Westminster,  CO  80234
Correspondent Contact DEBRA SONGER
Regulation Number866.5100
Classification Product Code
LJM  
Date Received10/28/1991
Decision Date 01/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-