The following data is part of a premarket notification filed by Genzyme Corporation with the FDA for Osom C. Difficile Toxin A/b Test.
| Device ID | K102242 |
| 510k Number | K102242 |
| Device Name: | OSOM C. DIFFICILE TOXIN A/B TEST |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | GENZYME CORPORATION 31 NEW YORK AVENUE Framingham, MA 01701 |
| Contact | Carol C Ryerson |
| Correspondent | Carol C Ryerson GENZYME CORPORATION 31 NEW YORK AVENUE Framingham, MA 01701 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-09 |
| Decision Date | 2010-12-21 |
| Summary: | summary |