The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Revolution Radial Immunodiffusion Plate.
| Device ID | K831811 |
| 510k Number | K831811 |
| Device Name: | REVOLUTION RADIAL IMMUNODIFFUSION PLATE |
| Classification | Plates And Equipment, Radial Immunodiffusion |
| Applicant | CALBIOCHEM-BEHRING CORP. 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 | 1983-06-06 |
| Decision Date | 1983-07-28 |