510(k) K212418
K212418 is an FDA 510(k) premarket notification submitted by Healstone Biotech, Inc. for the device "hCG One Step Pregnancy Test". The FDA issued a decision of Substantially Equivalent on June 30, 2022. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Healstone Biotech, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2022
- Date Received
- August 3, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Test, Pregnancy, Hcg, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type