510(k) K954920
K954920 is an FDA 510(k) premarket notification submitted by Murex Diagnostics, Inc. for the device "MUREX RUB-EX". The FDA issued a decision of Substantially Equivalent on August 21, 1996. The device falls under product code LQN (Latex Agglutination Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Murex Diagnostics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1996
- Date Received
- October 26, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Latex Agglutination Assay, Rubella
- Device Class
- Class II
- Regulation Number
- 866.3510
- Review Panel
- MI
- Submission Type