510(k) K141210
K141210 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS". The FDA issued a decision of Substantially Equivalent on January 29, 2015. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2015
- Date Received
- May 9, 2014
- 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