The following data is part of a premarket notification filed by Bd Diagnostics (geneohm Sciences, Inc.) with the FDA for Bd Geneohm Cdiff Assay.
| Device ID | K081920 |
| 510k Number | K081920 |
| Device Name: | BD GENEOHM CDIFF ASSAY |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) 6146 NANCY RIDGE DR. San Diego, CA 92121 |
| Contact | Raymond Boule |
| Correspondent | Raymond Boule BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) 6146 NANCY RIDGE DR. San Diego, CA 92121 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-03 |
| Decision Date | 2008-12-19 |
| Summary: | summary |