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FDA 510(k)

ELECSYS TOXO IGG CALCHECK

K-Number: K083655 · 2009-02-12

ApplicantRoche Diagnostics
Decision Date2009-02-12
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS TOXO IGG 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 2009-02-12 under 510(k) number K083655. 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 TOXO IGG CALCHECK?

ELECSYS TOXO IGG CALCHECK is a medical device that received FDA 510(k) clearance on 2009-02-12. The listed applicant is Roche Diagnostics. The 510(k) number is K083655.

When did ELECSYS TOXO IGG CALCHECK receive FDA 510(k) clearance?

ELECSYS TOXO IGG CALCHECK received FDA 510(k) clearance on 2009-02-12, under 510(k) number K083655.

Who is the listed applicant for ELECSYS TOXO IGG 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 ELECSYS TOXO IGG CALCHECK?

The FDA product code for ELECSYS TOXO IGG 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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