510(k) K130470
K130470 is an FDA 510(k) premarket notification submitted by Geneohm Sciences Canada, Inc. (Bd Diagnostics) for the device "BD MAX CDIFF ASSAY, BD MAX INSTRUMENT". The FDA issued a decision of Substantially Equivalent on April 2, 2013. The device falls under product code OZN (C. Difficile Toxin Gene Amplification Assay), a Class II device regulated under 21 CFR 866.3130. Geneohm Sciences Canada, Inc. (Bd Diagnostics) has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 2013
- Date Received
- February 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- C. Difficile Toxin Gene Amplification Assay
- Device Class
- Class II
- Regulation Number
- 866.3130
- Review Panel
- MI
- Submission Type
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.