510(k) K993473

SYNCHRON SYSTEMS DRUG CALIBRATOR 2 by Beckman Coulter, Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1999
Date Received
October 14, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type