510(k) K092355
K092355 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "MONOLISA ANTI-HAV EIA". The FDA issued a decision of Substantially Equivalent on October 29, 2009. The device falls under product code LOL (Hepatitis A Test (Antibody And Igm Antibody)), a Class II device regulated under 21 CFR 866.3310. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2009
- Date Received
- August 4, 2009
- 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