The following data is part of a premarket notification filed by Bd Diagnostics (geneohm Sciences, Inc.) with the FDA for Bd Geneohm Mrsa Acp Assay.
| Device ID | K093346 |
| 510k Number | K093346 |
| Device Name: | BD GENEOHM MRSA ACP ASSAY |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) 6146 NANCY RIDGE DR. San Diego, CA 92121 |
| Contact | Raymond Boule |
| Correspondent | Raymond Boule BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) 6146 NANCY RIDGE DR. 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 | 2009-10-26 |
| Decision Date | 2009-12-15 |
| Summary: | summary |