BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
FDA 510(k) clearance K081008 · decided 2008-12-22
Clearance details
- K-number
- K081008
- Device name
- BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
- Applicant
- Lin-Zhi International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-10
- Decision date
- 2008-12-22
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- DJG
- Device class
- 2
- Regulation number
- 862.3650
- 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 |
|---|---|---|
| Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vit recall (Z-1270-2014) | Lin-Zhi International Inc | 2014-03-21 |
| Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Di recall (Z-0386-2014) | Lin-Zhi International Inc | 2013-11-25 |