The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Immunocard Toxins A & B, Model 712050.
| Device ID | K041003 |
| 510k Number | K041003 |
| Device Name: | IMMUNOCARD TOXINS A & B, MODEL 712050 |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Susan Rolih |
| Correspondent | Susan Rolih MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-19 |
| Decision Date | 2004-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101786 | K041003 | 000 |