Calibration Pack, Models A9100-101S and A9100-103S

FDA 510(k) K023792 · Thermo Orion

Substantially Equivalent

510(k) numberK023792

Submission

Device name
Calibration Pack, Models A9100-101S and A9100-103S
Applicant
Thermo Orion
Beverly, MA, US
Received
November 13, 2002
Decision date
January 31, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JIX – Calibrator, Multi-Analyte Mixture
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1150
Specialty
Clinical Chemistry

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Questions and answers

When was Calibration Pack, Models A9100-101S and A9100-103S cleared by the FDA?

Calibration Pack, Models A9100-101S and A9100-103S (K023792) received a 510(k) decision of Substantially Equivalent on January 31, 2003, 79 days after the submission was received.

What is the product code of K023792?

The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.