The following data is part of a premarket notification filed by Sealite Sciences, Inc. with the FDA for Sealite Science, Inc. Aqualite(r) Lh.
| Device ID | K943188 |
| 510k Number | K943188 |
| Device Name: | SEALITE SCIENCE, INC. AQUALITE(R) LH |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | SEALITE SCIENCES, INC. 187 BEN BURTON CIRCLE Bogart, GA 30622 |
| Contact | David F Smith |
| Correspondent | David F Smith SEALITE SCIENCES, INC. 187 BEN BURTON CIRCLE Bogart, GA 30622 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-05 |
| Decision Date | 1994-10-20 |