The following data is part of a premarket notification filed by Neometrics, Inc. with the FDA for Accuwell Tsh, Model Kaw-tsh-960.
| Device ID | K001455 |
| 510k Number | K001455 |
| Device Name: | ACCUWELL TSH, MODEL KAW-TSH-960 |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | NEOMETRICS, INC. 104 BELLEROSE AVE. East Northport, NY 11731 |
| Contact | David Schwartz |
| Correspondent | David Schwartz NEOMETRICS, INC. 104 BELLEROSE AVE. East Northport, NY 11731 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-09 |
| Decision Date | 2000-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725609000618 | K001455 | 000 |