The following data is part of a premarket notification filed by Nipro Diagnostics, Inc with the FDA for True Metrix Air Self-monitoring Blood Glucose System, True Metrix Air Pro Professional Blood Gulcose Monitoring System.
| Device ID | K150052 |
| 510k Number | K150052 |
| Device Name: | TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Nipro Diagnostics, Inc 2400 NW 55th Court Fort Lauderdale, FL 33309 |
| Contact | Simeon Simone |
| Correspondent | Simeon Simone Nipro Diagnostics, Inc 2400 NW 55th Court Fort Lauderdale, FL 33309 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-12 |
| Decision Date | 2015-03-26 |