K831811 is an FDA 510(k) clearance for the REVOLUTION RADIAL IMMUNODIFFUSION PLATE. This device is classified as a Plates And Equipment, Radial Immunodiffusion (Class I - General Controls, product code JZQ).
Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1983, 52 days after receiving the submission on June 6, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4800.
| 510(k) Number | K831811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 1983 |
| Decision Date | July 28, 1983 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JZQ — Plates And Equipment, Radial Immunodiffusion |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.4800 |