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FDA 510(k)

ELECSYS PROLACTIN II CALCHECK 5

K-Number: K110613 · 2011-05-12

ApplicantRoche Diagnostics
Decision Date2011-05-12
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS PROLACTIN II 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 2011-05-12 under 510(k) number K110613. 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 PROLACTIN II CALCHECK 5?

ELECSYS PROLACTIN II CALCHECK 5 is a medical device that received FDA 510(k) clearance on 2011-05-12. The listed applicant is Roche Diagnostics. The 510(k) number is K110613.

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

ELECSYS PROLACTIN II CALCHECK 5 received FDA 510(k) clearance on 2011-05-12, under 510(k) number K110613.

Who is the listed applicant for ELECSYS PROLACTIN II 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 PROLACTIN II CALCHECK 5?

The FDA product code for ELECSYS PROLACTIN II 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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