picoAMH ELISA
FDA 510(k) clearance DEN180004 · decided 2018-10-24
Clearance details
- K-number
- DEN180004
- Device name
- picoAMH ELISA
- Applicant
- Ansh Labs, LLC
- Decision
- Unknown
- Date received
- 2018-01-22
- Decision date
- 2018-10-24
- Days to decision
- 275 days
- Clearance type
- Direct
- Product code
- QDH
- Device class
- 2
- Regulation number
- 862.1093
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Webster, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.