510(k) K925826
K925826 is an FDA 510(k) premarket notification submitted by Clark Laboratories, Inc. for the device "ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA". The FDA issued a decision of Substantially Equivalent on January 26, 1993. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Clark Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1993
- Date Received
- November 16, 1992
- 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