510(k) K183571
K183571 is an FDA 510(k) premarket notification submitted by Immucor, Inc. for the device "Capture-CMV". The FDA issued a decision of Substantially Equivalent on February 4, 2019. The device falls under product code LJO (Antigen, Iha, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Immucor, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2019
- Date Received
- December 21, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Iha, Cytomegalovirus
- Device Class
- Class II
- Regulation Number
- 866.3175
- Review Panel
- MI
- Submission Type