The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Ket-1 Blood Ketone Monitoring System.
| Device ID | K182593 |
| 510k Number | K182593 |
| Device Name: | KET-1 Blood Ketone Monitoring System |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | Apex Biotechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, TW 30078 |
| Contact | Lisa Liu |
| Correspondent | Lisa Liu Apex Biotechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, TW 30078 |
| Product Code | JIN |
| CFR Regulation Number | 862.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-20 |
| Decision Date | 2018-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860060002341 | K182593 | 000 |
| 00860060002334 | K182593 | 000 |
| 00860060002327 | K182593 | 000 |
| 00860060002310 | K182593 | 000 |