FDA 510(k) Application Details - K131928

Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone

  More FDA Info for this Device
510(K) Number K131928
Device Name Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant NANOEN TEK USA, INC.
1 JACKS' HILL ROAD, STE 1 (A&B)
OXFORD, CT 06478 US
Other 510(k) Applications for this Company
Contact JUDITH E LOEBEL
Other 510(k) Applications for this Contact
Regulation Number 862.1690

  More FDA Info for this Regulation Number
Classification Product Code JLW
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/27/2013
Decision Date 03/14/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact