K864319 is an FDA 510(k) clearance for the TDX(R) II ANALYZER. This device is classified as a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I - General Controls, product code JJQ).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on December 16, 1986, 43 days after receiving the submission on November 3, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2300.
| 510(k) Number | K864319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1986 |
| Decision Date | December 16, 1986 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2300 |