The following data is part of a premarket notification filed by Neometrics, Inc. with the FDA for Neocoat T4.
| Device ID | K901939 |
| 510k Number | K901939 |
| Device Name: | NEOCOAT T4 |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | NEOMETRICS, INC. 104BELLEROSE AVE. E. Northport, NY 11731 |
| Contact | David Schwartz |
| Correspondent | David Schwartz NEOMETRICS, INC. 104BELLEROSE AVE. E. Northport, NY 11731 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-30 |
| Decision Date | 1990-05-31 |