Cleared Traditional

CARESIDE ANALYZER

K981610 · Careside, Inc. · Chemistry
Jun 1998
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K981610 is an FDA 510(k) clearance for the CARESIDE ANALYZER, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on June 25, 1998, 56 days after receiving the submission on April 30, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.

Submission Details

510(k) Number K981610 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 1998
Decision Date June 25, 1998
Days to Decision 56 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
PICCOLO PHOSPHORUS TEST SYSTEM
K022312 · Abaxis, Inc. · Sep 2002
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
K013095 · Wiener Laboratories Saic · Nov 2001