FDA 510(k) Applications for Medical Device:
Test, Urine Leukocyte
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K063295 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K981555 | CHRONIMED, INC. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K971976 | DIA-SCREEN CORP. |
5182 WEST 76TH ST. | MINNEAPOLIS | MN | 55439 |
| K231045 | Healgen Scientific LLC |
5213 Maple St | Bellaire | TX | 77401 |
| K000578 | SERIM RESEARCH CORP. |
23565 REEDY DR. | ELKHART | IN | 46514 |
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