510(k) K872845
K872845 is an FDA 510(k) premarket notification submitted by Bion Ent., Ltd. for the device "BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM". The FDA issued a decision of Substantially Equivalent on August 17, 1987. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Bion Ent., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 1987
- Date Received
- July 20, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type