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 Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K001651
Device Name BIO-RAD %CDT TIA
Applicant
Axis-Shield Biochemicals, Asa
P.O. Box 262069
San Diego,  CA  92196
Applicant Contact RONALD G LEONARDI
Correspondent
Axis-Shield Biochemicals, Asa
P.O. Box 262069
San Diego,  CA  92196
Correspondent Contact RONALD G LEONARDI
Regulation Number862.1660
Classification Product Code
JJX  
Subsequent Product Codes
JIS   NAO  
Date Received05/30/2000
Decision Date 11/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-