The following data is part of a premarket notification filed by Awareness Technology, Inc. with the FDA for Dri-dye Check Strips (tm)-405.
| Device ID | K892656 |
| 510k Number | K892656 |
| Device Name: | DRI-DYE CHECK STRIPS (TM)-405 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | AWARENESS TECHNOLOGY, INC. P.O. DRAWER 1679 3481 SW PALM CITY SCHOOL ROAD Palm City, FL 34990 |
| Contact | Mary Freeman |
| Correspondent | Mary Freeman AWARENESS TECHNOLOGY, INC. P.O. DRAWER 1679 3481 SW PALM CITY SCHOOL ROAD Palm City, FL 34990 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1989-05-22 |