ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
FDA 510(k) clearance K050024 · decided 2005-11-17
Clearance details
- K-number
- K050024
- Device name
- ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-05
- Decision date
- 2005-11-17
- Days to decision
- 316 days
- Clearance type
- Traditional
- Product code
- DIS
- Device class
- 2
- Regulation number
- 862.3150
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Yardley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.