K780122 is an FDA 510(k) clearance for the HTSH RIA. This device is classified as a Fluorometer, For Clinical Use (Class I - General Controls, product code KHO).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 3, 1978, 11 days after receiving the submission on January 23, 1978.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2560.
| 510(k) Number | K780122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1978 |
| Decision Date | February 03, 1978 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KHO — Fluorometer, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2560 |