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 Sirolimus Test System
510(k) Number K070822
Device Name ARCHITECT SIROLIMUS ASSAY
Applicant
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.
Malvern,  PA  19355 -1308
Applicant Contact DIANA LYN DICKSON
Correspondent
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.
Malvern,  PA  19355 -1308
Correspondent Contact DIANA LYN DICKSON
Regulation Number862.3840
Classification Product Code
NRP  
Subsequent Product Code
JIT  
Date Received03/26/2007
Decision Date 09/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-