The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Mrsa/sa Bc (blood Culture) Assay Model Gxmrsa/sa-bc-10.
| Device ID | K101879 |
| 510k Number | K101879 |
| Device Name: | XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Contact | Russel K Enns, Ph.d. |
| Correspondent | Russel K Enns, Ph.d. CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Product Code | NQX |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-06 |
| Decision Date | 2010-07-28 |
| Summary: | summary |