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 |