FDA 510(k) Applications for Medical Device:
Blood, Occult, Colorimetric, In Urine
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K111221 | ACON LABORATORIES, INC. |
10125 MESA RIM RD. | SAN DIEGO | CA | 92121 |
| K040703 | DIRUI INDUSTRIAL CO., LTD. |
7560 LINDBERGH DRIVE | GAITHERSBURG | MD | 20879 |
| K111999 | HEALGEN SCIENTIFIC, LLC |
5213 MAPLE STREET | BELLAIRE | TX | 77401 |
| K023297 | TECO DIAGNOSTICS |
1268 . LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K232317 | URIT Medical Electronic Co., Ltd. |
NO. D-07 Information Industry District, High-Tech Zone, | Guilin | 541004 | |
| K082811 | URIT MEDICAL ELECTRONIC CO., LTD. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K083724 | WIENER LABORATORIOS S.A.I.C. |
2944 RIOBAMBA | ROSARIO | 2000 |
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