The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Immunocard C. Difficile Gdh.
| Device ID | K112048 |
| 510k Number | K112048 |
| Device Name: | IMMUNOCARD C. DIFFICILE GDH |
| Classification | Antigen, C. Difficile |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Susan Bogar |
| Correspondent | Susan Bogar MERIDIAN BIOSCIENCE, 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 | 2011-07-18 |
| Decision Date | 2011-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101793 | K112048 | 000 |