510(k) K200363
K200363 is an FDA 510(k) premarket notification submitted by Quidel Cardiovascular, Inc. for the device "Quidel Triage® TOX Drug Screen, 94600". The FDA issued a decision of Substantially Equivalent on March 11, 2020. 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
- March 11, 2020
- Date Received
- February 14, 2020
- Clearance Type
- Special
- 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