The following data is part of a premarket notification filed by Awareness Technology, Inc. with the FDA for Dye Check Strips 545-630.
| Device ID | K943729 |
| 510k Number | K943729 |
| Device Name: | DYE CHECK STRIPS 545-630 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | AWARENESS TECHNOLOGY, INC. 1995 SW MARTIN HWY. P.O. BOX 1679 Palm City, FL 34990 |
| Contact | Mary Freeman |
| Correspondent | Mary Freeman AWARENESS TECHNOLOGY, INC. 1995 SW MARTIN HWY. P.O. BOX 1679 Palm City, FL 34990 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1994-12-29 |