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 |