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FDA 510(k)

ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5

K-Number: K103221 · 2010-12-23

ApplicantRoche Diagnostics
Decision Date2010-12-23
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECYS HGH CALSET, ELECSYS HGH 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 2010-12-23 under 510(k) number K103221. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5?

ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 is a medical device that received FDA 510(k) clearance on 2010-12-23. The listed applicant is Roche Diagnostics. The 510(k) number is K103221.

When did ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 receive FDA 510(k) clearance?

ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 received FDA 510(k) clearance on 2010-12-23, under 510(k) number K103221.

Who is the listed applicant for ELECYS HGH CALSET, ELECSYS HGH 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 ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5?

The FDA product code for ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 is JIT.

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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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