The following data is part of a premarket notification filed by Geneohm Sciences Canada, Inc. (bd Diagnostics) with the FDA for Bd Max Staphsr Assay, Instrument.
| Device ID | K132822 |
| 510k Number | K132822 |
| Device Name: | BD MAX STAPHSR ASSAY, INSTRUMENT |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| 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 | NQX |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-09 |
| Decision Date | 2013-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904434199 | K132822 | 000 |