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, Antigen, Control
510(k) Number K893896
Device Name QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA
Applicant
Biostar Medical Products, Inc.
Suite 1203 Crystal Plz. Bld.1
2001 Jefferson Davis, Box 2286
Arlington,  VA  22202
Applicant Contact JERRY BERKSTRESSER
Correspondent
Biostar Medical Products, Inc.
Suite 1203 Crystal Plz. Bld.1
2001 Jefferson Davis, Box 2286
Arlington,  VA  22202
Correspondent Contact JERRY BERKSTRESSER
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received05/30/1989
Decision Date 07/14/1989
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
-
-