Alltest Pregnancy Rapid Combo Test Cassette
FDA 510(k) clearance K203272 · decided 2022-01-31
Clearance details
- K-number
- K203272
- Device name
- Alltest Pregnancy Rapid Combo Test Cassette
- Applicant
- Hangzhou AllTest Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-06
- Decision date
- 2022-01-31
- Days to decision
- 451 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.