510(k) K925689
K925689 is an FDA 510(k) premarket notification submitted by Fuller Laboratories, Inc. for the device "MERIDIAN EBV-IGG TEST KIT". The FDA issued a decision of Substantially Equivalent on October 12, 1993. The device falls under product code MCD (Antigen, Ebv, Capsid), a Class I device regulated under 21 CFR 866.3235. Fuller Laboratories, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 1993
- Date Received
- November 12, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Ebv, Capsid
- Device Class
- Class I
- Regulation Number
- 866.3235
- Review Panel
- MI
- Submission Type