Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
FDA 510(k) clearance K161214 · decided 2016-06-27
Clearance details
- K-number
- K161214
- Device name
- Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-04-29
- Decision date
- 2016-06-27
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- DIO
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Guangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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| Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set (K150925) | Immunalysis Corporation | 2015-06-29 |
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Recalls involving this device
No recalls on record reference this clearance.