The following data is part of a premarket notification filed by Remel Inc with the FDA for Prospect Clostridium Difficile Toxin A/b Microplate Assay.
| Device ID | K033479 |
| 510k Number | K033479 |
| Device Name: | PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | REMEL INC 14000 UNITY STREET NW Ramsey, MN 55303 |
| Contact | David Teicher |
| Correspondent | David Teicher REMEL INC 14000 UNITY STREET NW Ramsey, MN 55303 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-03 |
| Decision Date | 2004-02-26 |
| Summary: | summary |