MDI QUIK TEST NARCOTICS DRUG SCREEN
FDA 510(k) clearance K853140 · decided 1986-03-03
Clearance details
- K-number
- K853140
- Device name
- MDI QUIK TEST NARCOTICS DRUG SCREEN
- Applicant
- Medical Diagnostics, Ca.
- Decision
- Substantially Equivalent
- Date received
- 1985-07-29
- Decision date
- 1986-03-03
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- DNK
- Device class
- 2
- Regulation number
- 862.3640
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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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 |
| CR3 Keyless Split Sample Cup Morphine - Methamphetamine (K150602) | Guangzhou Wondfo Biotech Co., Ltd. | 2015-04-07 |
| ONE STEP MORPHINE CARD TEST (K970579) | Teco Diagnostics | 1997-07-03 |
Recalls involving this device
No recalls on record reference this clearance.