510(k) K052223
K052223 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS EPO ASSAY". The FDA issued a decision of Substantially Equivalent on October 6, 2006. The device falls under product code GGT (Assay, Erythropoietin), a Class II device regulated under 21 CFR 864.7250. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 2006
- Date Received
- August 15, 2005
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Erythropoietin
- Device Class
- Class II
- Regulation Number
- 864.7250
- Review Panel
- HE
- Submission Type