The following data is part of a premarket notification filed by American Dade with the FDA for Dade Chill Tray.
| Device ID | K822132 |
| 510k Number | K822132 |
| Device Name: | DADE CHILL TRAY |
| Classification | Regulator, Temperature |
| Applicant | AMERICAN DADE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JRR |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-20 |
| Decision Date | 1982-08-05 |