The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Premier Toxins A&b, Model 616096.
| Device ID | K993914 |
| 510k Number | K993914 |
| Device Name: | PREMIER TOXINS A&B, MODEL 616096 |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | David H Willis |
| Correspondent | David H Willis MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-17 |
| Decision Date | 1999-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101694 | K993914 | 000 |