510(k) K013095

WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 by Wiener Laboratories Saic — Product Code CEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2001
Date Received
September 17, 2001
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