FDA 510(k) Applications for Medical Device Product Code "MIU"
(Enzyme Linked Immunosorbent Assay, T. Cruzi)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K161947 | INBIOS INTERNATIONAL, INC. | Chagas Detect Plus Rapid Test | 12/16/2016 |
| K072732 | Ortho-Clinical Diagnostics, Inc. | ORTHO T. CRUZI ELISA TEST SYSTEM | 04/15/2009 |
| K023889 | WIENER LABORATORIES S.A.I.C. | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 | 02/11/2004 |
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