FDA 510(k) Application Details - K041643

Device Classification Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus

  More FDA Info for this Device
510(K) Number K041643
Device Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Applicant BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA, CA 92822 US
Other 510(k) Applications for this Company
Contact MARY BETH TANG
Other 510(k) Applications for this Contact
Regulation Number 862.1580

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

  More FDA Info for this Product Code
Date Received 06/17/2004
Decision Date 08/18/2004
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