510(k) K023369
K023369 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS TOTAL T4 ASSAY". The FDA issued a decision of Substantially Equivalent on December 9, 2002. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2002
- Date Received
- October 8, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- Device Class
- Class II
- Regulation Number
- 862.1700
- Review Panel
- CH
- Submission Type