The following data is part of a premarket notification filed by Bd Diagnostics (geneohm Sciences Canada, Inc) with the FDA for Bd Geneohm Staphsr Assay.
| Device ID | K071026 |
| 510k Number | K071026 |
| Device Name: | BD GENEOHM STAPHSR ASSAY |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) 6146 NANCY RIDGE DRIVE San Diego, CA 92121 |
| Contact | Raymond Boule |
| Correspondent | Raymond Boule BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) 6146 NANCY RIDGE DRIVE San Diego, CA 92121 |
| Product Code | NQX |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-11 |
| Decision Date | 2007-12-20 |
| Summary: | summary |