510(k) K970198
K970198 is an FDA 510(k) premarket notification submitted by Scimedx Corp. for the device "IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES". The FDA issued a decision of Substantially Equivalent on February 20, 1997. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Scimedx Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 1997
- Date Received
- January 21, 1997
- 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