510(k) K930010
K930010 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "ACCESS THYROID UPTAKE ASSAY". The FDA issued a decision of Substantially Equivalent on Jun 7, 1993. The device falls under product code CEE (Radioimmunoassay, Thyroxine-Binding Globulin), a Class II device regulated under 21 CFR 862.1685. Bio-Rad Laboratories, Inc. has 127 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 7, 1993
- Date Received
- Jan 4, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Thyroxine-Binding Globulin
- Device Class
- Class II
- Regulation Number
- 862.1685
- Review Panel
- CH
- Submission Type
- 510(k) Exempt