The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Automated Bloodborne Pathogen Test Equipment.
| Device ID | BK970042 |
| 510k Number | BK970042 |
| Device Name: | Automated Bloodborne Pathogen Test Equipment |
| Classification | Test, Equipment, Automated Bloodborne Pathogen |
| Applicant | Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064 |
| 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 | 1997-10-21 |
| Decision Date | 1999-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740050375 | BK970042 | 000 |
| 00380740038373 | BK970042 | 000 |
| 00380740027056 | BK970042 | 000 |
| 00380740012403 | BK970042 | 000 |
| 00380740008574 | BK970042 | 000 |
| 00380740008420 | BK970042 | 000 |
| 00380740007911 | BK970042 | 000 |
| 00380740007904 | BK970042 | 000 |