The following data is part of a premarket notification filed by Sealite Sciences, Inc. with the FDA for Aqualite Tsh Bioluminescent Immunoassay Kit.
| Device ID | K942661 |
| 510k Number | K942661 |
| Device Name: | AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Thyroid-stimulating 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 | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-06 |
| Decision Date | 1995-01-17 |