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FDA 510(k)

ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK

K-Number: K053059 · 2005-11-28

ApplicantRoche Diagnostics
Decision Date2005-11-28
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2005-11-28 under 510(k) number K053059. 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 ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK?

ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK is a medical device that received FDA 510(k) clearance on 2005-11-28. The listed applicant is Roche Diagnostics. The 510(k) number is K053059.

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

ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK received FDA 510(k) clearance on 2005-11-28, under 510(k) number K053059.

Who is the listed applicant for ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK?

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 ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK?

The FDA product code for ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK 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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