510(k) K241919
K241919 is an FDA 510(k) premarket notification submitted by Innovita (Tangshan) Biological Technology Co., Ltd. for the device "Innovita HCG Pregnancy Rapid Combo Test". The FDA issued a decision of Substantially Equivalent on August 2, 2024. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Innovita (Tangshan) Biological Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2024
- Date Received
- July 1, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Visual, Pregnancy Hcg, Prescription Use
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type