510(k) K191099
K191099 is an FDA 510(k) premarket notification submitted by Atlas Medical for the device "Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel". The FDA issued a decision of Substantially Equivalent on October 3, 2019. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Atlas Medical has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2019
- Date Received
- April 25, 2019
- 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