510(k) K890616
K890616 is an FDA 510(k) premarket notification submitted by Bion Ent., Ltd. for the device "BION DIRECT IDENTIFICATION CONTROL SLIDE". The FDA issued a decision of Substantially Equivalent on February 17, 1989. The device falls under product code LJG (Quality Control Slides), a Class I device regulated under 21 CFR 866.2660. Bion Ent., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1989
- Date Received
- February 7, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Quality Control Slides
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type