The following data is part of a premarket notification filed by Ocean Scientific, Inc. with the FDA for Ocean Scientific Vdrl Test.
| Device ID | K864731 |
| 510k Number | K864731 |
| Device Name: | OCEAN SCIENTIFIC VDRL TEST |
| Classification | Antigens, Nontreponemal, All |
| 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 | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-04 |
| Decision Date | 1987-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486000696 | K864731 | 000 |
| 10673486000689 | K864731 | 000 |