510(k) K932742
K932742 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "EBNA IGG ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on May 5, 1995. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), 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
- May 5, 1995
- Date Received
- June 8, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Antigen, Nuclear, Epstein-Barr Virus
- Device Class
- Class I
- Regulation Number
- 866.3235
- Review Panel
- MI
- Submission Type