510(k) K051484
K051484 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.". The FDA issued a decision of Substantially Equivalent on December 5, 2005. The device falls under product code LFY (Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2005
- Date Received
- June 6, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- Device Class
- Class II
- Regulation Number
- 866.3900
- Review Panel
- MI
- Submission Type