The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Meriview Tm Trichomonas.
| Device ID | K894246 |
| 510k Number | K894246 |
| Device Name: | MERIVIEW TM TRICHOMONAS |
| Classification | Kit, Screening, Trichomonas |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Michele Nickol |
| Correspondent | Michele Nickol MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | JWZ |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-21 |
| Decision Date | 1989-08-15 |