The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Tdx(r) Ii Analyzer.
| Device ID | K864319 |
| 510k Number | K864319 |
| Device Name: | TDX(R) II ANALYZER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | ABBOTT LABORATORIES 1921 HURD DR. P.O.BOX 152020 Irving, TX 75015 -2020 |
| Contact | Keith Minter |
| Correspondent | Keith Minter ABBOTT LABORATORIES 1921 HURD DR. P.O.BOX 152020 Irving, TX 75015 -2020 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-03 |
| Decision Date | 1986-12-16 |