The following data is part of a premarket notification filed by Sealite Sciences, Inc. with the FDA for Sealite Sciences Aqualite Fsh.
| Device ID | K970085 |
| 510k Number | K970085 |
| Device Name: | SEALITE SCIENCES AQUALITE FSH |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | SEALITE SCIENCES, INC. 3000 NORTHWOODS PKWY. Norcross, GA 30071 |
| Contact | Cathryn N Cambria |
| Correspondent | Cathryn N Cambria SEALITE SCIENCES, INC. 3000 NORTHWOODS PKWY. Norcross, GA 30071 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-10 |
| Decision Date | 1997-02-14 |
| Summary: | summary |