The following data is part of a premarket notification filed by Dynatech Corp. with the FDA for Immulon Substrate Removawell Strips.
| Device ID | K832117 |
| 510k Number | K832117 |
| Device Name: | IMMULON SUBSTRATE REMOVAWELL STRIPS |
| Classification | Device, General Purpose, Microbiology, Diagnostic |
| Applicant | DYNATECH CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LIB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-30 |
| Decision Date | 1983-08-08 |