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FDA 510(k)

ELECSYS INSULIN CALCHECK 5

K-Number: K101075 · 2010-06-11

ApplicantRoche Diagnostics Corp.
Decision Date2010-06-11
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS INSULIN CALCHECK 5 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2010-06-11 under 510(k) number K101075. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS INSULIN CALCHECK 5?

ELECSYS INSULIN CALCHECK 5 is a medical device that received FDA 510(k) clearance on 2010-06-11. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K101075.

When did ELECSYS INSULIN CALCHECK 5 receive FDA 510(k) clearance?

ELECSYS INSULIN CALCHECK 5 received FDA 510(k) clearance on 2010-06-11, under 510(k) number K101075.

Who is the listed applicant for ELECSYS INSULIN CALCHECK 5?

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

What is the FDA product code for ELECSYS INSULIN CALCHECK 5?

The FDA product code for ELECSYS INSULIN CALCHECK 5 is JJX.

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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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