The following data is part of a premarket notification filed by Elitech with the FDA for Mrsa/sa Elite Mgb.
| Device ID | K112937 |
| 510k Number | K112937 |
| Device Name: | MRSA/SA ELITE MGB |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | ELITECH 21720 23RD DRIVE SE, SUITE 150 Bothell, WA 98021 |
| Contact | Debra K Hutson |
| Correspondent | Debra K Hutson ELITECH 21720 23RD DRIVE SE, SUITE 150 Bothell, WA 98021 |
| Product Code | NQX |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2012-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661540950001 | K112937 | 000 |