Eurotrol Gas - Ise Control

FDA 510(k) K955340 · Direct Solutions

Substantially Equivalent

510(k) numberK955340

Submission

Device name
Eurotrol Gas - Ise Control
Applicant
Direct Solutions
Westford, MA, US
Received
November 20, 1995
Decision date
December 26, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JJS – Controls For Blood-Gases, (Assayed And Unassayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Specialty
Clinical Chemistry

Other 510(k)s with product code JJS

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K152553CueSee HypoxicJJS · Traditional Eurotrol B.V.04/22/2016SE
K150226Hematocrit and Metabolite QUALICHECKJJS · Traditional Radiometer Medical Aps05/13/2015SE
K130415High Metabolite QualicheckJJS · Traditional Radiometer Medical Aps03/26/2013SE
K130236Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3JJS · Traditional Radiometer Medical Aps03/15/2013SE
K033063Mission ControlsJJS · Traditional Diamond Diagnostics, Inc.12/12/2003SE
K022529Liquichek Blood Gas Plus Co-Oximeter Control (Il Synthesis Series) Levels 1,2, and 3…JJS · Traditional Bio-Rad08/15/2002SE
K022525Liquichek Blood Gas Plus Co-Oximeter Control (Radiometer 700 Series) Levels, 1,2 and 3…JJS · Traditional Bio-Rad08/15/2002SE
K003242Liquichek Blood Gas Plus Co-Oximeter Control (Il), Model 621,622,623JJS · Traditional Bio-Rad11/30/2000SE
K003239Liquichek Blood Gas Plus Co-Oximeter Control (800 Series), MODEL504,505,506JJS · Traditional Bio-Rad11/30/2000SE
K002866Liquichek Blood Gas Plus E Control Level 4, Model 574JJS · Traditional Bio-Rad09/25/2000SE

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K964053Hemocue GlucotrolJJX · Traditional 11/01/1996SE
K963908Hemocue HemolinGGM · Traditional 10/16/1996SE

Questions and answers

When was Eurotrol Gas - Ise Control cleared by the FDA?

Eurotrol Gas - Ise Control (K955340) received a 510(k) decision of Substantially Equivalent on December 26, 1995, 36 days after the submission was received.

What is the product code of K955340?

The FDA product code is JJS – Controls For Blood-Gases, (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.