FDA 510(k) Applications for Medical Device:
Antigen, Iha, Cytomegalovirus
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K001767 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K974901 | DIGENE CORP. |
9000 VIRGINIA MANOR RD., | BELTSVILLE | MD | 20705 |
| K951851 | E.I. DUPONT DE NEMOURS & CO., INC. |
BUILDING 500, MAILBOX 514 | NEWARK | DE | 19714-6101 |
| K183571 | Immucor, Inc. |
3130 Gateway Drive | Norcross | GA | 30071 |
| K203612 | Immucor, Inc. |
3130 Gateway Drive | Norcross | GA | 30071 |
| K974456 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K955799 | SIENNA BIOTECH, INC. |
3 BETHESDA METRO CENTER | BETHESDA | MD | 20814 |
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