K070987 is an FDA 510(k) clearance for the SENTINEL LITHIUM ASSAY. This device is classified as a Assay, Porphyrin, Spectrophotometry, Lithium (Class II - Special Controls, product code NDW).
Submitted by SENTINEL CH. SpA (Milan, IT). The FDA issued a Cleared decision on August 2, 2007, 118 days after receiving the submission on April 6, 2007.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3560.
| 510(k) Number | K070987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2007 |
| Decision Date | August 02, 2007 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | NDW - Assay, Porphyrin, Spectrophotometry, Lithium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3560 |