K881675 is an FDA 510(k) clearance for the IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS. This device is classified as a Plates And Equipment, Radial Immunodiffusion (Class I — General Controls, product code JZQ).
Submitted by Dynatech Laboratories, Inc. (Chantilly, US). The FDA issued a Cleared decision on April 21, 1988, 3 days after receiving the submission on April 18, 1988.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4800.
| 510(k) Number | K881675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 1988 |
| Decision Date | April 21, 1988 |
| Days to Decision | 3 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 |