The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Diamond Prima Blood Glucose Monitoring System, Fora Diamond Mini Blood Glucose Monitoring System.
| Device ID | K111890 |
| 510k Number | K111890 |
| Device Name: | FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU DISTRICT New Taipei City, TW 24888 |
| Contact | Meiru Li |
| Correspondent | Meiru Li TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU DISTRICT New Taipei City, TW 24888 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-01 |
| Decision Date | 2012-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042011962 | K111890 | 000 |