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 a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2017-04-26 under approval 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. It is manufactured by Roche Diagnostics. The 510(k) number is K170938.
When was CalSet IGF-1 approved by the FDA?
CalSet IGF-1 received FDA 510(k) clearance on 2017-04-26, under approval number K170938.
What company makes CalSet IGF-1?
CalSet IGF-1 is manufactured by Roche Diagnostics.
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.