K851253 is an FDA 510(k) clearance for the TDX ANALYZER W/NEPHELOMETRY CAROUSEL. This device is classified as a Nephelometer, For Clinical Use (Class I - General Controls, product code JQX).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on April 30, 1985, 33 days after receiving the submission on March 28, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2700.
| 510(k) Number | K851253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1985 |
| Decision Date | April 30, 1985 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JQX — Nephelometer, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2700 |