Cleared Traditional

PHOSPHORUS (INORGANIC)

K881171 · Tech-Co, Inc. · Chemistry
Apr 1988
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K881171 is an FDA 510(k) clearance for the PHOSPHORUS (INORGANIC), a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on April 28, 1988, 38 days after receiving the submission on March 21, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.

Submission Details

510(k) Number K881171 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1988
Decision Date April 28, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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