510(k) K041643

SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT by Beckman Coulter, Inc. — Product Code CEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2004
Date Received
June 17, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Device Class
Class I
Regulation Number
862.1580
Review Panel
CH
Submission Type