510(k) K190968
K190968 is an FDA 510(k) premarket notification submitted by Microgenics Corporation for the device "CEDIA Benzodiazepine Assay". The FDA issued a decision of Substantially Equivalent on December 9, 2019. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Microgenics Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2019
- Date Received
- April 12, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Benzodiazepine
- Device Class
- Class II
- Regulation Number
- 862.3170
- Review Panel
- TX
- Submission Type