The following data is part of a premarket notification filed by Dynatech Corp. with the FDA for Immulon Removawell Strips #011-010-6301.
| Device ID | K802857 |
| 510k Number | K802857 |
| Device Name: | IMMULON REMOVAWELL STRIPS #011-010-6301 |
| Classification | Device, Microtiter Diluting/dispensing |
| Applicant | DYNATECH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTC |
| CFR Regulation Number | 866.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-12 |
| Decision Date | 1980-12-11 |