The following data is part of a premarket notification filed by Sealite Sciences, Inc. with the FDA for Sealite Sciences Inc..
| Device ID | K941983 |
| 510k Number | K941983 |
| Device Name: | SEALITE SCIENCES INC. |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | SEALITE SCIENCES, INC. 187 BEN BURTON CIRCLE Bogart, GA 30622 |
| Contact | David F Smith, Ph.d |
| Correspondent | David F Smith, Ph.d SEALITE SCIENCES, INC. 187 BEN BURTON CIRCLE Bogart, GA 30622 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-25 |
| Decision Date | 1994-08-18 |