The following data is part of a premarket notification filed by Nipro Diagnostics, Inc. with the FDA for True Metrix Self-monitoring Blood Glucose System, True Metrix Professional Monitoring Blood Glucose System.
| Device ID | K120989 |
| 510k Number | K120989 |
| Device Name: | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | NIPRO DIAGNOSTICS, INC. 2200 W Cypress Creek Rd Fort Lauderdale, FL 33309 |
| Contact | Karen Devincent |
| Correspondent | Karen Devincent NIPRO DIAGNOSTICS, INC. 2200 W Cypress Creek Rd Fort Lauderdale, FL 33309 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-02 |
| Decision Date | 2013-04-24 |