The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Automated Bloodborne Pathogen Test Equipment.
| Device ID | BK140196 |
| 510k Number | BK140196 |
| Device Name: | Automated Bloodborne Pathogen Test Equipment |
| Classification | Test, Equipment, Automated Bloodborne Pathogen |
| Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive p.o. Box 9002 Pleasanton,, CA 94588 |
| Product Code | MZA |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-13 |
| Decision Date | 2016-10-20 |