K851154 is an FDA 510(k) clearance for the ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18. This device is classified as a Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (Class I — General Controls, product code JQT).
Submitted by Astral Medical Systems (Buena Park, US). The FDA issued a Cleared decision on May 13, 1985, 52 days after receiving the submission on March 22, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2400.
| 510(k) Number | K851154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1985 |
| Decision Date | May 13, 1985 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JQT — Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2400 |