The following data is part of a premarket notification filed by Sealite Sciences, Inc. with the FDA for Aqualite Intact Pth.
| Device ID | K970483 |
| 510k Number | K970483 |
| Device Name: | AQUALITE INTACT PTH |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | SEALITE SCIENCES, INC. 3000 NORTHWOODS PKWY., #200 Norcross, GA 30071 |
| Contact | Cathryn N Cambria |
| Correspondent | Cathryn N Cambria SEALITE SCIENCES, INC. 3000 NORTHWOODS PKWY., #200 Norcross, GA 30071 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-10 |
| Decision Date | 1997-04-14 |
| Summary: | summary |