CalSet IGF-1

FDA 510(k) K170938 · Roche Diagnostics

Substantially Equivalent

510(k) numberK170938

Submission

Device name
CalSet IGF-1
Applicant
Roche Diagnostics
Indianapolis, IN, US
Received
March 30, 2017
Decision date
April 26, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JIT – Calibrator, Secondary
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1150
Specialty
Clinical Chemistry

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Questions and answers

When was CalSet IGF-1 cleared by the FDA?

CalSet IGF-1 (K170938) received a 510(k) decision of Substantially Equivalent on April 26, 2017, 27 days after the submission was received.

What is the product code of K170938?

The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.