510(k) K961012
K961012 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "VZV IGG ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 24, 1996. 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
- July 24, 1996
- Date Received
- March 13, 1996
- 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