510(k) K051484

ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. by Zeus Scientific, Inc. — Product Code LFY

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