510(k) K043067
K043067 is an FDA 510(k) premarket notification submitted by Bioarray Solutions, Ltd. for the device "ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400". The FDA issued a decision of Substantially Equivalent on May 31, 2005. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2005
- Date Received
- November 8, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extractable Antinuclear Antibody, Antigen And Control
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type