FDA 510(k) Application Details - K914820

Device Classification Name Radioimmunoassay, Immunoreactive Insulin

  More FDA Info for this Device
510(K) Number K914820
Device Name Radioimmunoassay, Immunoreactive Insulin
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER, TX US
Other 510(k) Applications for this Company
Contact JOHNNY R WILLIS
Other 510(k) Applications for this Contact
Regulation Number 862.1405

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

  More FDA Info for this Product Code
Date Received 10/25/1991
Decision Date 01/09/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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