The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Accraassay Rid Kits.
| Device ID | K761311 |
| 510k Number | K761311 |
| Device Name: | ACCRAASSAY RID KITS |
| Classification | Plates And Equipment, Radial Immunodiffusion |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JZQ |
| CFR Regulation Number | 866.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-12-23 |
| Decision Date | 1976-12-30 |