|
Device | HEPATITS C CHECK TEST SYSTEM |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | PWNHealth Chicago LLC 123 W 18th Street New York, NY 10002 |
PMA Number | P980046 |
Supplement Number | S007 |
Date Received | 12/03/2004 |
Decision Date | 12/10/2004 |
Product Code |
MZO |
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 TO A SUPPLIER OF A COMPONENT OF THE HEPATITIS C CHECK TEST SYSTEM. |