The following data is part of a premarket notification filed by Trividia Health, Inc. with the FDA for True Metrix Go Self Monitoring Blood Glucose System.
| Device ID | K143548 |
| 510k Number | K143548 |
| Device Name: | TRUE METRIX GO Self Monitoring Blood Glucose System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Trividia Health, Inc. 2400 NW 55TH COURT Fort Lauderdale, FL 33309 |
| Contact | Beth Foster |
| Correspondent | Roberto Cunha Trividia Health, Inc. 2400 NW 55TH COURT Fort Lauderdale, FL 33309 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-15 |
| Decision Date | 2016-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10708820721095 | K143548 | 000 |
| 10021292006119 | K143548 | 000 |
| 10021292009332 | K143548 | 000 |
| 10021292009790 | K143548 | 000 |
| 00021292012991 | K143548 | 000 |
| 10021292013117 | K143548 | 000 |
| 00021292007706 | K143548 | 000 |
| 10041220136138 | K143548 | 000 |
| 10050428560409 | K143548 | 000 |
| 10311917178698 | K143548 | 000 |
| 10011822002780 | K143548 | 000 |