Nipro Diagnostics, Inc.
FDA Regulatory Profile
Nipro Diagnostics, Inc. appears in FDA public data with 3 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0910-2014, Class II) was initiated on October 2, 2013. Its most recent 510(k) clearance was granted on March 26, 2015.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0910-2014 | Class II | MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Pa | October 2, 2013 |
| Z-0909-2014 | Class II | MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Pa | October 2, 2013 |
| Z-1140-2013 | Class II | Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Gluco | February 25, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K150052 | TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose | March 26, 2015 |
| K140100 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUC | August 1, 2014 |
| K132072 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCO | August 15, 2013 |
| K120989 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE | April 24, 2013 |