TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)
FDA 510(k) clearance K032657 · decided 2004-03-24
Clearance details
- K-number
- K032657
- Device name
- TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)
- Applicant
- Home Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-28
- Decision date
- 2004-03-24
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Fort Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing recall (Z-0910-2014) | Nipro Diagnostics, Inc. | 2014-02-03 |
| Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Bloo recall (Z-1140-2013) | Nipro Diagnostics, Inc. | 2013-04-18 |