510(k) K102242 ยท LLH Reagents, Clostridium Difficile Toxin
OSOM C. DIFFICILE TOXIN A/B TEST
| Applicant | Genzyme Corporation, Framingham MA, US |
| Decision | Substantially Equivalent, Dec 21, 2010 |
| Received | Aug 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102242
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2013 | Sekisui Diagnostics LLC Product Name: OSOM C. Difficile Toxin A/B Test
Catalog Numbers: 173 (for United States) and 173 E (for Europe).
The Test is a qualitative assay (in vitro diagnostic) that employs
immunochromatographi Terminated |
LLH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.