Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | ELECSYS ANTI-HBS IMMUNOASSAY |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P010054 |
Supplement Number | S015 |
Date Received | 07/12/2011 |
Decision Date | 08/08/2011 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE THE IN-PROCESS METHOD TO DETERMINE THE PARTICLE CONCENTRATION OF THE ELECSYS COATED MICROPARTICLES (BEADS). |
|
|