The following data is part of a premarket notification filed by Geneohm Sciences Canada, Inc. (bd Diagnostics) with the FDA for Bd Max Cdiff Assay, Bd Max Instrument.
| Device ID | K130470 |
| 510k Number | K130470 |
| Device Name: | BD MAX CDIFF ASSAY, BD MAX INSTRUMENT |
| Classification | C. Difficile Toxin Gene Amplification Assay |
| Applicant | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 2555 Boul. Du Parc-Technologique Quebec, CA G1p 4s5 |
| Contact | Patricia Dionne |
| Correspondent | Patricia Dionne GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 2555 Boul. Du Parc-Technologique Quebec, CA G1p 4s5 |
| Product Code | OZN |
| CFR Regulation Number | 866.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-25 |
| Decision Date | 2013-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904434182 | K130470 | 000 |