510(k) K894203
K894203 is an FDA 510(k) premarket notification submitted by Kronus for the device "ANTI-THYROGLOBULIN TEST KIT". The FDA issued a decision of Substantially Equivalent on July 25, 1989. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Kronus has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 1989
- Date Received
- June 19, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Thyroid Autoantibody
- Device Class
- Class II
- Regulation Number
- 866.5870
- Review Panel
- IM
- Submission Type