The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Meritec-totavirus Latex Detection Procedure.
| Device ID | K850269 |
| 510k Number | K850269 |
| Device Name: | MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Richard Walter |
| Correspondent | Richard Walter MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-23 |
| Decision Date | 1985-07-18 |