The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Immulon 4 Flat Bottom Plates & Removawell Strips.
| Device ID | K881675 |
| 510k Number | K881675 |
| Device Name: | IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS |
| Classification | Plates And Equipment, Radial Immunodiffusion |
| Applicant | DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Contact | Richard K Prescott |
| Correspondent | Richard K Prescott DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Product Code | JZQ |
| CFR Regulation Number | 866.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-18 |
| Decision Date | 1988-04-21 |