510(k) K203272
K203272 is an FDA 510(k) premarket notification submitted by Hangzhou AllTest Biotech Co., Ltd. for the device "Alltest Pregnancy Rapid Combo Test Cassette". The FDA issued a decision of Substantially Equivalent on January 31, 2022. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Hangzhou AllTest Biotech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2022
- Date Received
- November 6, 2020
- 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