The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Dynalume(tm) Removawell Strips (no. 011-010-7403).
| Device ID | K864863 |
| 510k Number | K864863 |
| Device Name: | DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403) |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Contact | Barry S Lazar |
| Correspondent | Barry S Lazar DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-11 |
| Decision Date | 1987-01-13 |