Cleared Traditional

PICCOLO PHOSPHORUS TEST SYSTEM

K022312 · Abaxis, Inc. · Chemistry
Sep 2002
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K022312 is an FDA 510(k) clearance for the PICCOLO PHOSPHORUS TEST SYSTEM, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on September 5, 2002, 50 days after receiving the submission on July 17, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.

Submission Details

510(k) Number K022312 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2002
Decision Date September 05, 2002
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEO — Phosphomolybdate (colorimetric), Inorganic Phosphorus
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1580

Similar Devices — CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus

All 104
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
K100263 · Seppim S.A.S. · May 2011
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
K072141 · Alfa Wassermann Diagnostic Technologies, Inc. · Jun 2008
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
K041643 · Beckman Coulter, Inc. · Aug 2004
ATAC PAK PHOSPHORUS REAGENT
K030015 · Elan Diagnostics · Mar 2003
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
K013095 · Wiener Laboratories Saic · Nov 2001
PHOSPHORUS REAGENT
K003912 · Jas Diagnostics, Inc. · Feb 2001