Submission Details
| 510(k) Number | K081920 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 03, 2008 |
| Decision Date | December 19, 2008 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
BD GENEOHM CDIFF ASSAY
Dec 2008
Decision
169d
Days
Class 1
Risk
About This 510(k) Submission
K081920 is an FDA 510(k) clearance for the BD GENEOHM CDIFF ASSAY, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Bd Diagnostics (Geneohm Sciences, Inc.) (San Diego, US). The FDA issued a Cleared decision on December 19, 2008, 169 days after receiving the submission on July 3, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.
Device Classification
| Product Code | LLH — Reagents, Clostridium Difficile Toxin |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2660 |
Manufacturer
Similar Devices — LLH Reagents, Clostridium Difficile Toxin
All 41
K193490 · First Light Diagnostics, Inc.
· Jul 2021
K102242 · Genzyme Corporation
· Dec 2010
K091109 · Cepheid
· Jul 2009
K090239 · Prodesse, Inc.
· Apr 2009
K082499 · Techlab, Inc.
· Mar 2009
K080931 · bioMerieux, Inc.
· Jun 2008