FDA 510(k) Application Details - DEN180004

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180004
Device Name	picoAMH ELISA
Applicant	Ansh Labs LLC 445 Medical Center Blvd. Webster, TX 77598 US Other 510(k) Applications for this Company
Contact	Ajay Kumar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2018
Decision Date	10/24/2018
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review