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 antibodies, anti-cyclic citrullinated peptide (ccp)
510(k) Number K112810
Device Name MULTI-ANALYTE DETECTION SYSTEMS
Applicant
Bio-Rad Laboratories
BIOPLEX 2200 DIVISION
5500 EAST SECOND ST
BENICIA,  CA  94510
Applicant Contact Juang Wang
Correspondent
Bio-Rad Laboratories
BIOPLEX 2200 DIVISION
5500 EAST SECOND ST
BENICIA,  CA  94510
Correspondent Contact Juang Wang
Regulation Number866.5775
Classification Product Code
NHX  
Date Received09/27/2011
Decision Date 10/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-