• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name calibrator, secondary
510(k) Number K043095
Device Name ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
p.o. box 50416
indianapolis,  IN  46250 -0457
Original Contact kay a taylor
Regulation Number862.1150
Classification Product Code
JIT  
Date Received11/09/2004
Decision Date 11/23/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-