510(k) K100903
K100903 is an FDA 510(k) premarket notification submitted by Roche Professional Diagnostics for the device "ANTI-HAV". The FDA issued a decision of Substantially Equivalent on October 5, 2010. 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 Professional Diagnostics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2010
- Date Received
- April 1, 2010
- 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