510(k) K190428
K190428 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Anti-HAV II". The FDA issued a decision of Substantially Equivalent on August 13, 2019. The device falls under product code LOL (Hepatitis A Test (Antibody And Igm Antibody)), a Class II device regulated under 21 CFR 866.3310. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2019
- Date Received
- February 22, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hepatitis A Test (Antibody And Igm Antibody)
- Device Class
- Class II
- Regulation Number
- 866.3310
- Review Panel
- MI
- Submission Type