Ansh Labs, LLC
FDA Regulatory Profile
Ansh Labs, LLC appears in FDA public data with 1 recall, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0842-2021, Class II) was initiated on December 18, 2020. Its most recent 510(k) clearance was granted on October 24, 2018.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0842-2021 | Class II | AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, I | December 18, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN180004 | picoAMH ELISA | October 24, 2018 |