510(k) K014173

SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR by Beckman Coulter, Inc. — Product Code DKJ

K014173 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR". The FDA issued a decision of Substantially Equivalent on February 15, 2002. The device falls under product code DKJ (Colorimetry, Salicylate), a Class II device regulated under 21 CFR 862.3830. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2002
Date Received
December 20, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Salicylate
Device Class
Class II
Regulation Number
862.3830
Review Panel
TX
Submission Type