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FDA 510(k)

ELECSYS IGE CALCHECK 5

K-Number: K102269 · 2010-10-07

ApplicantRoche Diagnostics
Decision Date2010-10-07
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS IGE CALCHECK 5 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2010-10-07 under 510(k) number K102269. 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 IGE CALCHECK 5?

ELECSYS IGE CALCHECK 5 is a medical device that received FDA 510(k) clearance on 2010-10-07. The listed applicant is Roche Diagnostics. The 510(k) number is K102269.

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

ELECSYS IGE CALCHECK 5 received FDA 510(k) clearance on 2010-10-07, under 510(k) number K102269.

Who is the listed applicant for ELECSYS IGE CALCHECK 5?

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 ELECSYS IGE CALCHECK 5?

The FDA product code for ELECSYS IGE 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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