The following data is part of a premarket notification filed by Wako Intl., Inc. with the FDA for Seri-sep Serum/plasma Islolator.
| Device ID | K781629 |
| 510k Number | K781629 |
| Device Name: | SERI-SEP SERUM/PLASMA ISLOLATOR |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | WAKO INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-25 |
| Decision Date | 1978-10-27 |