FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BD GENEOHM CDIFF ASSAY
K Number: K081920
·
Decision Dec 19, 2008
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
41
Applicant Total
2
Review Days
169
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Basic Information
- Device Name
- BD GENEOHM CDIFF ASSAY
- K Number
- K081920
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bd Diagnostics (Geneohm Sciences, Inc.)
- Date Received
- July 3, 2008
- Decision Date
- December 19, 2008
- Product Code
- LLH
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | FDA class 1 | Microbiology |
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Other Clearances by Bd Diagnostics (Geneohm Sciences, Inc.)
| K Number | Device Name | ||
|---|---|---|---|
| K093346 | BD GENEOHM MRSA ACP ASSAY | Dec 15, 2009 | Substantially Equivalent |