510(k) K002905
K002905 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER". The FDA issued a decision of Substantially Equivalent on October 19, 2000. The device falls under product code MSW (System, Test, Thyroglobulin), a Class II device regulated under 21 CFR 866.6010. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2000
- Date Received
- September 18, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Thyroglobulin
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type