K981801 is an FDA 510(k) clearance for the ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA. This device is classified as a U.v. Spectrometry, Tricyclic Antidepressant Drugs (Class II - Special Controls, product code LFH).
Submitted by Princeton BioMeditech Corp. (Princeton, US). The FDA issued a Cleared decision on August 25, 1998, 96 days after receiving the submission on May 21, 1998.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3910.
| 510(k) Number | K981801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1998 |
| Decision Date | August 25, 1998 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | LFH — U.v. Spectrometry, Tricyclic Antidepressant Drugs |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3910 |