The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Meritec(tm) - C. Difficile Latex Test System.
| Device ID | K895915 |
| 510k Number | K895915 |
| Device Name: | MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM |
| Classification | Antigen, C. Difficile |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Nickol, Phd |
| Correspondent | Nickol, Phd MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | MCB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-10 |
| Decision Date | 1990-03-12 |