CR3 Keyless Split Sample Cup Morphine - Methamphetamine
FDA 510(k) clearance K150602 · decided 2015-04-07
Clearance details
- K-number
- K150602
- Device name
- CR3 Keyless Split Sample Cup Morphine - Methamphetamine
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-10
- Decision date
- 2015-04-07
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DNK
- Device class
- 2
- Regulation number
- 862.3640
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Guangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine (K151557) | Nantong Egens Biotech Co., Ltd. | 2015-07-16 |
| ONE STEP MORPHINE CARD TEST (K970579) | Teco Diagnostics | 1997-07-03 |
| MDI QUIK TEST NARCOTICS DRUG SCREEN (K853140) | Medical Diagnostics, Ca. | 1986-03-03 |
Recalls involving this device
No recalls on record reference this clearance.