The following data is part of a premarket notification filed by Gen-probe with the FDA for Automated Bloodborne Pathogen Test Equipment.
| Device ID | BK060021 |
| 510k Number | BK060021 |
| Device Name: | Automated Bloodborne Pathogen Test Equipment |
| Classification | Test, Equipment, Automated Bloodborne Pathogen |
| Applicant | Gen-Probe 10210 Genetic Center Drive San Diego, CA 92121 |
| 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 | 2006-04-20 |
| Decision Date | 2007-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045500709 | BK060021 | 000 |