The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Control Solution, Taidoc Control Solution.
| Device ID | K093724 |
| 510k Number | K093724 |
| Device Name: | FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Contact | Debra Liang |
| Correspondent | Debra Liang TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-03 |
| Decision Date | 2010-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888277176747 | K093724 | 000 |
| 00816042011993 | K093724 | 000 |
| 00816042012006 | K093724 | 000 |
| 00898939002048 | K093724 | 000 |
| 00898939002055 | K093724 | 000 |
| 00898939002062 | K093724 | 000 |
| 00898939002406 | K093724 | 000 |
| 00898939002413 | K093724 | 000 |
| 00898939002420 | K093724 | 000 |
| 00816042014383 | K093724 | 000 |