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 Anti-Sm Antibody, Antigen And Control
510(k) Number K024219
Device Name LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
Applicant
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618 -2017
Applicant Contact Yvette Lloyd
Correspondent
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618 -2017
Correspondent Contact Yvette Lloyd
Regulation Number866.5100
Classification Product Code
LKP  
Date Received12/23/2002
Decision Date 01/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-