The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Tox Tm Analyzer.
| Device ID | K811263 |
| 510k Number | K811263 |
| Device Name: | TOX TM ANALYZER |
| Classification | Polarimeter |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | JQZ |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-06 |
| Decision Date | 1981-05-29 |