510(k) K893240
K893240 is an FDA 510(k) premarket notification submitted by Bion Ent., Ltd. for the device "BION EBV-M (VCA) TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 14, 1989. The device falls under product code LJN (Antibody Igm, If, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Bion Ent., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 1989
- Date Received
- April 28, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antibody Igm, If, Epstein-Barr Virus
- Device Class
- Class I
- Regulation Number
- 866.3235
- Review Panel
- MI
- Submission Type