K781153 is an FDA 510(k) clearance for the KIDNEY, ARTIFICIAL. This device is classified as a Thin Layer Chromatography, Methamphetamine (Class II - Special Controls, product code DJC).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 17, 1978, 99 days after receiving the submission on July 10, 1978.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3610.
| 510(k) Number | K781153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1978 |
| Decision Date | October 17, 1978 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DJC — Thin Layer Chromatography, Methamphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3610 |