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FDA 510(k)

CalSet IGF-1

K-Number: K170938 · 2017-04-26

ApplicantRoche Diagnostics
Decision Date2017-04-26
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CalSet IGF-1 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2017-04-26 under 510(k) number K170938. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CalSet IGF-1?

CalSet IGF-1 is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Roche Diagnostics. The 510(k) number is K170938.

When did CalSet IGF-1 receive FDA 510(k) clearance?

CalSet IGF-1 received FDA 510(k) clearance on 2017-04-26, under 510(k) number K170938.

Who is the listed applicant for CalSet IGF-1?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CalSet IGF-1?

The FDA product code for CalSet IGF-1 is JIT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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