FDA 510(k) Application Details - K022874

Device Classification Name System, Transport, Aerobic

  More FDA Info for this Device
510(K) Number K022874
Device Name System, Transport, Aerobic
Applicant GEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO, CA 92121-4362 US
Other 510(k) Applications for this Company
Contact ALAN MADERAZO
Other 510(k) Applications for this Contact
Regulation Number 866.2900

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

  More FDA Info for this Product Code
Date Received 07/26/2002
Decision Date 09/17/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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