510(k) K951320
K951320 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "AURAFLEX TG-AB AND TPO-AB". The FDA issued a decision of Substantially Equivalent on August 25, 1995. The device falls under product code JNL (Immunochemical, Thyroglobulin Autoantibody), a Class II device regulated under 21 CFR 866.5870. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 1995
- Date Received
- March 23, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunochemical, Thyroglobulin Autoantibody
- Device Class
- Class II
- Regulation Number
- 866.5870
- Review Panel
- IM
- Submission Type