The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Immulon 1,2,3,and 4 Dividastrips Tm.
| Device ID | K894645 |
| 510k Number | K894645 |
| Device Name: | IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM |
| Classification | Device, Microtiter Diluting/dispensing |
| Applicant | DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Contact | Barry Lazar |
| Correspondent | Barry Lazar DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Product Code | JTC |
| CFR Regulation Number | 866.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-10-17 |