AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
FDA 510(k) clearance K201630 · decided 2021-08-12
Clearance details
- K-number
- K201630
- Device name
- AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
- Applicant
- Assure Tech. (Hangzhou) Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-06-16
- Decision date
- 2021-08-12
- Days to decision
- 422 days
- Clearance type
- Traditional
- Product code
- DJG
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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.