FDA 510(k) Applications for Medical Device:
Latex Agglutination Assay, Rubella
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K031490 | IMMUNOSTICS, INC. |
3505 SUNSET AVE. | OCEAN | NJ | 07712 |
| K954920 | MUREX DIAGNOSTICS, INC. |
3075 NORTHWOODS CIR. | NORCROSS | GA | 30071-1542 |
| K952544 | SERADYN, INC. |
1200 MADISON AVE. | INDIANAPOLIS | IN | 46225 |
| K961784 | SIENNA BIOTECH, INC. |
9115 GUILFORD RD. | COLUMBIA | MD | 21046-1893 |
| K970931 | SIENNA BIOTECH, INC. |
9115 GUILFORD RD. | COLUMBIA | MD | 21046-1893 |
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