FDA 510(k) Application Details - K760821

Device Classification Name Hydrazone Colorimetry, Aldolase

  More FDA Info for this Device
510(K) Number K760821
Device Name Hydrazone Colorimetry, Aldolase
Applicant SIGMA CHEMICAL CO.

, US
Other 510(k) Applications for this Company
Regulation Number 862.1040

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

  More FDA Info for this Product Code
Date Received 10/13/1976
Decision Date 10/21/1976
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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