510(k) K924091
K924091 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "EBV-VCA IGG ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on January 11, 1993. The device falls under product code MCD (Antigen, Ebv, Capsid), a Class I device regulated under 21 CFR 866.3235. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 1993
- Date Received
- August 13, 1992
- 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