510(k) K182719
K182719 is an FDA 510(k) premarket notification submitted by Quidel Cardiovascular, Inc. for the device "Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro". The FDA issued a decision of Substantially Equivalent on June 19, 2019. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Quidel Cardiovascular, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2019
- Date Received
- September 28, 2018
- 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