FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
FDA 510(k) clearance K052115 · decided 2005-12-29
Clearance details
- K-number
- K052115
- Device name
- FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
- Applicant
- First Check Diagnostics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-08-04
- Decision date
- 2005-12-29
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- DKZ
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen Dr recall (Z-0152-2012) | Ameditech Inc | 2011-11-03 |