510(k) K042118
K042118 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ATHENA MULTI-LYTE EBV IGG TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on April 29, 2005. The device falls under product code JRY (Antiserum, Fluorescent, 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
- April 29, 2005
- Date Received
- August 6, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Fluorescent, Epstein-Barr Virus
- Device Class
- Class I
- Regulation Number
- 866.3235
- Review Panel
- MI
- Submission Type