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. |
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Device | IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Siemens Healthcare Diagnostics Products, LTD GLYN RHONWY LLANBERIS, CAERNARFON LL55 |
PMA Number | P010051 |
Supplement Number | S003 |
Date Received | 08/17/2005 |
Decision Date | 11/02/2005 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS WHICH ADD AN INCOMING RAW MATERIAL TEST. |
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