Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475

FDA 510(k) K100060 · Vital Diagnostics (Manufacturing) Ptyltd

Substantially Equivalent

510(k) numberK100060

Submission

Device name
Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475
Applicant
Vital Diagnostics (Manufacturing) Ptyltd
Noble Park, AU
Received
January 11, 2010
Decision date
December 15, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KHS – Enzymatic, Carbon-Dioxide
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1160
Specialty
Clinical Chemistry

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Questions and answers

When was Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475 cleared by the FDA?

Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475 (K100060) received a 510(k) decision of Substantially Equivalent on December 15, 2010, 338 days after the submission was received.

What is the product code of K100060?

The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.