Submission Details
| 510(k) Number | K190579 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 06, 2019 |
| Decision Date | June 04, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
TD-4183 Blood Glucose Monitoring System
Jun 2019
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K190579 is an FDA 510(k) clearance for the TD-4183 Blood Glucose Monitoring System, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on June 4, 2019, 90 days after receiving the submission on March 6, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.
Device Classification
| Product Code | NBW — System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1345 |
Manufacturer
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