510(k) K152590
K152590 is an FDA 510(k) premarket notification submitted by Coretests, Inc. for the device "ACCU NEWS Drug Screening Test Card/Urine Cup". The FDA issued a decision of Substantially Equivalent on April 15, 2016. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Coretests, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2016
- Date Received
- September 10, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Amphetamine
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type