FDA 510(k) Application Details - K965240

Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

  More FDA Info for this Device
510(K) Number K965240
Device Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Applicant BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD.
W-337
BREA, CA 92821-6208 US
Other 510(k) Applications for this Company
Contact SHERI HALL
Other 510(k) Applications for this Contact
Regulation Number 862.2160

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

  More FDA Info for this Product Code
Date Received 12/30/1996
Decision Date 03/10/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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