510(k) K903843
K903843 is an FDA 510(k) premarket notification submitted by General Biometrics, Inc. for the device "IMMUNODOT THYROID AUTOIMMUNITY PANEL". The FDA issued a decision of Substantially Equivalent on October 2, 1990. The device falls under product code JNL (Immunochemical, Thyroglobulin Autoantibody), a Class II device regulated under 21 CFR 866.5870. General Biometrics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1990
- Date Received
- August 21, 1990
- 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