510(k) DEN180004
- Device
- picoAMH ELISA
- Applicant
- Ansh Labs, LLC
- 510(k) number
- DEN180004
- Product code
- QDH
- Decision
- Unknown (DENG)
- Decision date
- 2018-10-24
- Date received
- 2018-01-22
- Regulation
- 862.1093
- Classification name
- Menopause Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Ajay Kumar
- Address
- 445 Medical Center Blvd. Webster TX US 77598 77598
FDA Registration Numbers#
- 3008198807
Source Documents#
510(k) summary PDF not indicated by FDA