Cleared Traditional

BLOOD GAS/ISE LINEARITY CONTROL

K920285 · Phoenix Diagnostics, Inc. · Chemistry
Jul 1992
Decision
174d
Days
Class 1
Risk

About This 510(k) Submission

K920285 is an FDA 510(k) clearance for the BLOOD GAS/ISE LINEARITY CONTROL, a Controls For Blood-gases, (assayed And Unassayed) (Class I — General Controls, product code JJS), submitted by Phoenix Diagnostics, Inc. (Natick, US). The FDA issued a Cleared decision on July 14, 1992, 174 days after receiving the submission on January 22, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K920285 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1992
Decision Date July 14, 1992
Days to Decision 174 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJS — Controls For Blood-gases, (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

Similar Devices — JJS Controls For Blood-gases, (assayed And Unassayed)

All 66
CueSee Hypoxic
K152553 · Eurotrol B.V. · Apr 2016
Hematocrit and Metabolite QUALICHECK
K150226 · Radiometer Medical Aps · May 2015
HIGH METABOLITE QUALICHECK
K130415 · Radiometer Medical Aps · Mar 2013
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
K130236 · Radiometer Medical Aps · Mar 2013
MISSION CONTROLS
K033063 · Diamond Diagnostics, Inc. · Dec 2003
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
K022525 · Bio-Rad · Aug 2002