The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Genesis Health Technologies Blood Glucose Monitoring System.
| Device ID | K121224 |
| 510k Number | K121224 |
| Device Name: | GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City, TW 24888 |
| Contact | Linda Ko |
| Correspondent | Linda Ko TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City, TW 24888 |
| Product Code | LFR |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-20 |
| Decision Date | 2012-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00713757465007 | K121224 | 000 |
| 00713757464802 | K121224 | 000 |