FDA 510(k) Applications for Medical Device:
Kit, Direct Antigen, Positive Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K972182 | ABBOTT DIAGNOSTICS |
200 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-3537 |
| K083744 | BINAX, INC. |
10 SOUTHGATE RD. | SCARBOROUGH | ME | 04074 |
| K972129 | BLACKHAWK BIOSYSTEMS, INC. |
12945 ALCOSTA BLVD. | SAN RAMON | CA | 94583 |
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