K894328 is an FDA 510(k) clearance for the TDX(R) LITES(TM) LITHIUM. This device is classified as a Flame Photometry, Lithium (Class II - Special Controls, product code JIH).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 13, 1989, 122 days after receiving the submission on July 14, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3560.
| 510(k) Number | K894328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1989 |
| Decision Date | November 13, 1989 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIH — Flame Photometry, Lithium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3560 |