510(k) K933251
K933251 is an FDA 510(k) premarket notification submitted by Virion (U.S.), Inc. for the device "EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST". The FDA issued a decision of Substantially Equivalent on June 13, 1994. The device falls under product code MCD (Antigen, Ebv, Capsid), a Class I device regulated under 21 CFR 866.3235. Virion (U.S.), Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1994
- Date Received
- July 2, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Ebv, Capsid
- Device Class
- Class I
- Regulation Number
- 866.3235
- Review Panel
- MI
- Submission Type