The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Mrsa/sa Test.
| Device ID | K142721 |
| 510k Number | K142721 |
| Device Name: | Cobas MRSA/SA Test |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton, CA 94588 -2722 |
| Contact | Wilk Von Gustedt |
| Correspondent | Wilk Von Gustedt ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE 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 | 2014-09-23 |
| Decision Date | 2014-12-17 |
| Summary: | summary |