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 c-reactive protein, antigen, antiserum, and control
510(k) Number K041155
Device Name WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
Applicant
STANBIO LABORATORY
1261 NORTH MAIN ST.
BOERNE,  TX  78006
Applicant Contact ADAOBI OGUCHI
Correspondent
STANBIO LABORATORY
1261 NORTH MAIN ST.
BOERNE,  TX  78006
Correspondent Contact ADAOBI OGUCHI
Regulation Number866.5270
Classification Product Code
DCK  
Subsequent Product Codes
JIT   JIX  
Date Received05/03/2004
Decision Date 10/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-