K072732 is an FDA 510(k) clearance for the ORTHO T. CRUZI ELISA TEST SYSTEM. This device is classified as a Enzyme Linked Immunosorbent Assay, T. Cruzi (Class I - General Controls, product code MIU).
Submitted by Ortho-Clinical Diagnostics, Inc. (Raritan, US). The FDA issued a Cleared decision on April 15, 2009, 567 days after receiving the submission on September 26, 2007.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3870.
| 510(k) Number | K072732 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2007 |
| Decision Date | April 15, 2009 |
| Days to Decision | 567 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MIU — Enzyme Linked Immunosorbent Assay, T. Cruzi |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3870 |