BD GENEOHM CDIFF ASSAY
FDA 510(k) clearance K081920 · decided 2008-12-19
Clearance details
- K-number
- K081920
- Device name
- BD GENEOHM CDIFF ASSAY
- Applicant
- Bd Diagnostics (Geneohm Sciences, Inc.)
- Decision
- Substantially Equivalent
- Date received
- 2008-07-03
- Decision date
- 2008-12-19
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- LLH
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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| TOX A/B QUICK CHEK (K050891) | Techlab, Inc. | 2005-07-25 |
| XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (K041951) | Remel, Inc. | 2004-11-15 |
| IMMUNOCARD TOXINS A & B, MODEL 712050 (K041003) | Meridian Bioscience, Inc. | 2004-08-20 |
| C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 (K032897) | Ivd Research, Inc. | 2004-05-27 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/ recall (Z-0790-2014) | Becton Dickinson & Co. | 2014-01-17 |
| BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnosti recall (Z-2318-2012) | Becton Dickinson & Co. | 2012-09-06 |
| BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sci recall (Z-2319-2012) | Becton Dickinson & Co. | 2012-09-06 |
| BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, recall (Z-2174-2010) | Becton Dickinson & Co. | 2010-08-05 |