Submission Details
| 510(k) Number | K844710 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 03, 1984 |
| Decision Date | January 07, 1985 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K844710 is an FDA 510(k) clearance for the EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD, a Apparatus, Electrophoresis, For Clinical Use (Class I — General Controls, product code JJN), submitted by Logos Scientific, Inc. (Henderson, US). The FDA issued a Cleared decision on January 7, 1985, 35 days after receiving the submission on December 3, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2485.
| 510(k) Number | K844710 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 03, 1984 |
| Decision Date | January 07, 1985 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJN — Apparatus, Electrophoresis, For Clinical Use |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2485 |