• 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 K030775
Device Name AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM
Applicant
IMMUNO CONCEPTS, N.A., LTD
2280 SPRINGLAKE RD.
SUITE 106
DALLAS,  TX  75234
Applicant Contact ERIC S HOY
Correspondent
IMMUNO CONCEPTS, N.A., LTD
2280 SPRINGLAKE RD.
SUITE 106
DALLAS,  TX  75234
Correspondent Contact ERIC S HOY
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received03/11/2003
Decision Date 05/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-