The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Hsv 1 And 2 Test.
| Device ID | K150617 |
| 510k Number | K150617 |
| Device Name: | Cobas HSV 1 And 2 Test |
| Classification | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Applicant | ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton, CA 94588 -2722 |
| Contact | David W. Gates |
| Correspondent | David W. Gates ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton, CA 94588 -2722 |
| Product Code | OQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-10 |
| Decision Date | 2015-06-01 |
| Summary: | summary |