The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Lightcycler Mrsa Advanced Test For Use With The Lightcycler 2.0 Instrument, Model 05205727.
| Device ID | K091409 |
| 510k Number | K091409 |
| Device Name: | LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Contact | Larry Pietrelli |
| Correspondent | Larry Pietrelli ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Product Code | NQX |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-13 |
| Decision Date | 2010-07-06 |
| Summary: | summary |