The following data is part of a premarket notification filed by Elitechgroup Epoch Biosciences with the FDA for Mrsa/sa Elite Mgb, Elite Mgb Software.
| Device ID | K132468 |
| 510k Number | K132468 |
| Device Name: | MRSA/SA ELITE MGB, ELITE MGB SOFTWARE |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | ELITechGroup Epoch Biosciences 21720 23RD DR SE, SUITE 150 Bothell, WA 98021 |
| Contact | Debra K Hutson |
| Correspondent | Debra K Hutson ELITechGroup Epoch Biosciences 21720 23RD DR SE, SUITE 150 Bothell, WA 98021 |
| Product Code | NQX |
| Subsequent Product Code | JJH |
| Subsequent Product Code | NSU |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-07 |
| Decision Date | 2013-10-17 |
| Summary: | summary |