FDA 510(k) Applications for Medical Device:
Legionella, Spp., Elisa
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K982238 | BINAX, INC. |
217 READ ST. | PORTLAND | ME | 04103 |
| K991074 | INTRACEL CORP. |
1330 PICCARD DR. | ROCKVILLE | MD | 20850 |
| K070522 | INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS |
10 SOUTHGATE RD. | SCARBOROUGH | ME | 04074 |
| K113190 | MERIDIAN BIOSCIENCE, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K163273 | MERIDIAN BIOSCIENCE, INC. |
3471 RIVER HILLS DRIVE | CINCINNATI | OH | 45244 |
| K061496 | SA SCIENTIFIC LTD. |
4919 GOLDEN QUAIL | SAN ANTONIO | TX | 78240 |
| K191184 | SSI Diagnostica A/S |
2 Herredsvejen | Hilleroed | 3400 | |
| K033051 | TRINITY BIOTECH USA |
P.O. BOX 1059 | JAMESTOWN | NY | 14702-1059 |
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