The following data is part of a premarket notification filed by Remel Inc with the FDA for Xpect Clostridium Difficile Toxin A/b.
| Device ID | K041951 |
| 510k Number | K041951 |
| Device Name: | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | REMEL INC 12076 SANTA FE DRIVE Lenexa, KS 66215 |
| Contact | Mary Ann Silvius |
| Correspondent | Mary Ann Silvius REMEL INC 12076 SANTA FE DRIVE Lenexa, KS 66215 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-20 |
| Decision Date | 2004-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30848838068417 | K041951 | 000 |
| 30848838027094 | K041951 | 000 |