510(k) K981521
K981521 is an FDA 510(k) premarket notification submitted by Tosoh Medics, Inc. for the device "AIA-PACK TPOAB ASSAY". The FDA issued a decision of Substantially Equivalent on October 8, 1998. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Tosoh Medics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 1998
- Date Received
- April 28, 1998
- 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