510(k) K961204
K961204 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "MUMPS IGG TEST". The FDA issued a decision of Substantially Equivalent on July 18, 1996. The device falls under product code LJY (Enzyme Linked Immunoabsorbent Assay, Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 1996
- Date Received
- March 27, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Linked Immunoabsorbent Assay, Mumps Virus
- Device Class
- Class I
- Regulation Number
- 866.3380
- Review Panel
- MI
- Submission Type