The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Immulon 1 Eia Tubes, Immulon 2 Eia Tubes.
| Device ID | K854423 |
| 510k Number | K854423 |
| Device Name: | IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES |
| Classification | Device, General Purpose, Microbiology, Diagnostic |
| Applicant | DYNATECH LABORATORIES, INC. 900 SLATERS LN. Alexandria, VA 22314 |
| Contact | Barry S Lazar |
| Correspondent | Barry S Lazar DYNATECH LABORATORIES, INC. 900 SLATERS LN. Alexandria, VA 22314 |
| Product Code | LIB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-05 |
| Decision Date | 1985-11-20 |