FDA 510(k) Application Details - K962615

Device Classification Name Strip, Test Isoniazid

  More FDA Info for this Device
510(K) Number K962615
Device Name Strip, Test Isoniazid
Applicant FERGUSON MEDICAL
3407 BAY AVE.
CHICO, CA 95973-8619 US
Other 510(k) Applications for this Company
Contact FRANK FERGUSON
Other 510(k) Applications for this Contact
Regulation Number 000.0000

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

  More FDA Info for this Product Code
Date Received 07/03/1996
Decision Date 03/19/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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