510(k) K172745
K172745 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "ImmuGlo HEp-2 Elite IFA". The FDA issued a decision of Substantially Equivalent on June 5, 2018. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2018
- Date Received
- September 12, 2017
- 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