510(k) K901054
K901054 is an FDA 510(k) premarket notification submitted by Bion Ent., Ltd. for the device "BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE". The FDA issued a decision of Substantially Equivalent on April 5, 1990. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Bion Ent., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 1990
- Date Received
- March 6, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent, Borrelia Serological Reagent
- Device Class
- Class II
- Regulation Number
- 866.3830
- Review Panel
- MI
- Submission Type