AllTest Strep A Rapid Test
FDA 510(k) clearance K260342 · decided 2026-04-30
Clearance details
- K-number
- K260342
- Device name
- AllTest Strep A Rapid Test
- Applicant
- Hangzhou AllTest Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-02-02
- Decision date
- 2026-04-30
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- GTY
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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.