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FDA 510(k)

ELECSYS RUBELLA IGGA CALCHECK 5

K-Number: K092585 · 2009-10-30

ApplicantRoche Diagnostics
Decision Date2009-10-30
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS RUBELLA IGGA 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 2009-10-30 under 510(k) number K092585. 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 RUBELLA IGGA CALCHECK 5?

ELECSYS RUBELLA IGGA CALCHECK 5 is a medical device that received FDA 510(k) clearance on 2009-10-30. The listed applicant is Roche Diagnostics. The 510(k) number is K092585.

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

ELECSYS RUBELLA IGGA CALCHECK 5 received FDA 510(k) clearance on 2009-10-30, under 510(k) number K092585.

Who is the listed applicant for ELECSYS RUBELLA IGGA 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 RUBELLA IGGA CALCHECK 5?

The FDA product code for ELECSYS RUBELLA IGGA 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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