The following data is part of a premarket notification filed by Fenwal, Inc. with the FDA for Automated Bloodborne Pathogen Test Equipment.
| Device ID | BK920026 |
| 510k Number | BK920026 |
| Device Name: | Automated Bloodborne Pathogen Test Equipment |
| Classification | Test, Equipment, Automated Bloodborne Pathogen |
| Applicant | Fenwal, Inc. 25212 W. Illinois Route 120, Rlp-34 round Lake, Il 60073 Round Lake, IL 60073 |
| 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 | 1992-07-23 |
| Decision Date | 1993-07-30 |