The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Ortho T. Cruzi Elisa Test System.
| Device ID | K072732 |
| 510k Number | K072732 |
| Device Name: | ORTHO T. CRUZI ELISA TEST SYSTEM |
| Classification | Enzyme Linked Immunosorbent Assay, T. Cruzi |
| Applicant | Ortho-Clinical Diagnostics, Inc. 1001 U.S. HWY. 202 Raritan, NJ 08869 -0606 |
| Contact | Andrea J Casper |
| Correspondent | Andrea J Casper Ortho-Clinical Diagnostics, Inc. 1001 U.S. HWY. 202 Raritan, NJ 08869 -0606 |
| Product Code | MIU |
| CFR Regulation Number | 866.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-26 |
| Decision Date | 2009-04-15 |
| Summary: | summary |