FDA 510(k) Application Details - K803054

Device Classification Name Solution, Formalin-Sodium Acetate

  More FDA Info for this Device
510(K) Number K803054
Device Name Solution, Formalin-Sodium Acetate
Applicant REMEL CO.

, US
Other 510(k) Applications for this Company
Regulation Number 864.4010

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

  More FDA Info for this Product Code
Date Received 12/02/1980
Decision Date 12/22/1980
Decision SE - Substantially Equivalent
Classification Advisory Committee MI - Microbiology
Review Advisory Committee PA - Pathology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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