K761311 is an FDA 510(k) clearance for the ACCRAASSAY RID KITS. This device is classified as a Plates And Equipment, Radial Immunodiffusion (Class I - General Controls, product code JZQ).
Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1976, 7 days after receiving the submission on December 23, 1976.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4800.
| 510(k) Number | K761311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1976 |
| Decision Date | December 30, 1976 |
| Days to Decision | 7 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 |