The following data is part of a premarket notification filed by Awareness Technology, Inc. with the FDA for Focus-ghb.
| Device ID | K871679 |
| 510k Number | K871679 |
| Device Name: | FOCUS-GHB |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | AWARENESS TECHNOLOGY, INC. 3481 SW PALM CITY SCH. RD. P.O. BOX 1679 Palm City, FL 34990 |
| Contact | Mary Freeman |
| Correspondent | Mary Freeman AWARENESS TECHNOLOGY, INC. 3481 SW PALM CITY SCH. RD. P.O. BOX 1679 Palm City, FL 34990 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-29 |
| Decision Date | 1987-07-28 |