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 Pro Professional Monitoring Blood Glucose System.
Device ID | K140100 |
510k Number | K140100 |
Device Name: | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | NIPRO DIAGNOSTICS, INC. 2400 NW 55TH COURT Fort Lauderdale, FL 33309 |
Contact | Beth Foster |
Correspondent | Beth Foster NIPRO DIAGNOSTICS, 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 | 2014-01-15 |
Decision Date | 2014-08-01 |