The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Ultrawash Ii.
| Device ID | K863624 |
| 510k Number | K863624 |
| Device Name: | ULTRAWASH II |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Contact | Richard Prescott |
| Correspondent | Richard Prescott DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-16 |
| Decision Date | 1986-10-21 |