510(k) K221990
K221990 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access Total ßhCG (5th IS)". The FDA issued a decision of Substantially Equivalent on December 27, 2022. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2022
- Date Received
- July 6, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Human Chorionic Gonadotropin
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type