FDA 510(k) Applications for Medical Device:
Kit, Serological, Positive Control
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K101434 | AALTO SCIENTIFIC LTD. |
1959 KELLOGG AVE. | CARLSBAD | CA | 92008 |
| K972986 | BOSTON BIOMEDICA, INC. |
375 WEST ST. | WEST BRIDGEWATER | MA | 02379 |
| K030067 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K974262 | SCANTIBODIES LABORATORY, INC. |
9336 ABRAHAM WAY | SANTEE | CA | 92071 |
| K970100 | SIMPLICITY DIAGNOSTICS, INC. |
31 NORTH YORK RD. | HATBORO | PA | 19040 |
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