AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
FDA 510(k) clearance K244043 · decided 2025-02-27
Clearance details
- K-number
- K244043
- Device name
- AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
- Applicant
- Hangzhou AllTest Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-12-30
- Decision date
- 2025-02-27
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- NFT
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hangzhou AllTest Biotech Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.