The following data is part of a premarket notification filed by Mast Group Ltd. with the FDA for Mastalex -mrsa, Model Rst501.
| Device ID | K062864 |
| 510k Number | K062864 |
| Device Name: | MASTALEX -MRSA, MODEL RST501 |
| Classification | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| Applicant | MAST GROUP LTD. MAST HOUSE, DERBY RD. Bootle, Merseyside, GB L20 1ea |
| Contact | Barbara A Lee |
| Correspondent | Barbara A Lee MAST GROUP LTD. MAST HOUSE, DERBY RD. Bootle, Merseyside, GB L20 1ea |
| Product Code | MYI |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-25 |
| Decision Date | 2006-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060392372705 | K062864 | 000 |