510(k) K991610
K991610 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.". The FDA issued a decision of Substantially Equivalent on June 25, 1999. The device falls under product code DDC (Thyroglobulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5870. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 1999
- Date Received
- May 10, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thyroglobulin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5870
- Review Panel
- IM
- Submission Type