The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Tdx Analyzer W/nephelometry Carousel.
| Device ID | K851253 |
| 510k Number | K851253 |
| Device Name: | TDX ANALYZER W/NEPHELOMETRY CAROUSEL |
| Classification | Nephelometer, For Clinical Use |
| Applicant | ABBOTT LABORATORIES 1921 HURD DR. P.O.BOX 152020 Irving, TX 75015 -2020 |
| Contact | Beverly G Chambers |
| Correspondent | Beverly G Chambers ABBOTT LABORATORIES 1921 HURD DR. P.O.BOX 152020 Irving, TX 75015 -2020 |
| Product Code | JQX |
| CFR Regulation Number | 862.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-28 |
| Decision Date | 1985-04-30 |