FDA 510(k) Applications for Medical Device:
Enzyme Linked Immunosorbent Assay, T. Cruzi
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K161947 | INBIOS INTERNATIONAL, INC. |
562 1ST AVE. S. SUITE 600 | SEATTLE | WA | 98104 |
| K072732 | Ortho-Clinical Diagnostics, Inc. |
1001 U.S. HWY. 202 | RARITAN | NJ | 08869-0606 |
| K023889 | WIENER LABORATORIES S.A.I.C. |
2944 RIOBAMBA | ROSARIO | 2000 |
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