MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
FDA 510(k) clearance K051088 · decided 2005-06-24
Clearance details
- K-number
- K051088
- Device name
- MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
- Applicant
- Lin-Zhi International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-28
- Decision date
- 2005-06-24
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- DKB
- Device class
- 2
- Regulation number
- 862.3200
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Synnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in- recall (Z-0847-2012) | Lin-Zhi International Inc | 2012-01-25 |
| Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro recall (Z-0868-2012) | Lin-Zhi International Inc | 2012-01-25 |
| Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use only. Lin-Zh recall (Z-0838-2012) | Lin-Zhi International Inc | 2012-01-23 |