510(k) K862814
K862814 is an FDA 510(k) premarket notification submitted by Institute Virion , Ltd. for the device "COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI". The FDA issued a decision of Substantially Equivalent on September 30, 1986. The device falls under product code LQP (Campylobacter Spp.), a Class I device regulated under 21 CFR 866.3110. Institute Virion , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1986
- Date Received
- July 24, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Campylobacter Spp.
- Device Class
- Class I
- Regulation Number
- 866.3110
- Review Panel
- MI
- Submission Type