Cleared Traditional

DC-LINEATE CAT. NO. SE-091

K932555 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry
Aug 1993
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K932555 is an FDA 510(k) clearance for the DC-LINEATE CAT. NO. SE-091, a Calibrator, Primary (Class II — Special Controls, product code JIS), submitted by Diagnostic Chemicals, Ltd. (Usa) (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on August 19, 1993, 85 days after receiving the submission on May 26, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K932555 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 1993
Decision Date August 19, 1993
Days to Decision 85 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIS — Calibrator, Primary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

Similar Devices — JIS Calibrator, Primary

All 129
DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
K122126 · Randox Laboratories Limited · Aug 2012
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
K061251 · Dade Behring, Inc. · May 2006
DIMENSION IRON CALIBRATOR
K060266 · Dade Behring, Inc. · Mar 2006
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
K053104 · Dade Behring, Inc. · Dec 2005
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
K032697 · Dade Behring, Inc. · Nov 2003
GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER
K032608 · Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB · Oct 2003