The following data is part of a premarket notification filed by Ocean Scientific, Inc. with the FDA for Ocean Scientific Vacutest.
| Device ID | K863976 |
| 510k Number | K863976 |
| Device Name: | OCEAN SCIENTIFIC VACUTEST |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | OCEAN SCIENTIFIC, INC. 3740 EXPRESS DRIVE SOUTH Islandia, NY 11779 |
| Contact | Nicholas Vernola |
| Correspondent | Nicholas Vernola OCEAN SCIENTIFIC, INC. 3740 EXPRESS DRIVE SOUTH Islandia, NY 11779 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-14 |
| Decision Date | 1986-10-24 |