The following data is part of a premarket notification filed by Awareness Technology, Inc. with the FDA for Chemwell, Also Known As Project 2900.
| Device ID | K013420 |
| 510k Number | K013420 |
| Device Name: | CHEMWELL, ALSO KNOWN AS PROJECT 2900 |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | AWARENESS TECHNOLOGY, INC. 1995 SW MARTIN HWY. P.O. BOX 1679 Palm City, FL 34990 |
| Contact | Glen Van Slooten |
| Correspondent | Glen Van Slooten AWARENESS TECHNOLOGY, INC. 1995 SW MARTIN HWY. P.O. BOX 1679 Palm City, FL 34990 |
| Product Code | JLW |
| Subsequent Product Code | CDP |
| Subsequent Product Code | KLT |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2002-07-19 |