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FDA 510(k)

ELECSYS ANTI-TPO CALCHECK

K-Number: K001014 · 2000-06-01

ApplicantRoche Diagnostics Corp.
Decision Date2000-06-01
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS ANTI-TPO CALCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2000-06-01 under 510(k) number K001014. 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 ANTI-TPO CALCHECK?

ELECSYS ANTI-TPO CALCHECK is a medical device that received FDA 510(k) clearance on 2000-06-01. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K001014.

When did ELECSYS ANTI-TPO CALCHECK receive FDA 510(k) clearance?

ELECSYS ANTI-TPO CALCHECK received FDA 510(k) clearance on 2000-06-01, under 510(k) number K001014.

Who is the listed applicant for ELECSYS ANTI-TPO CALCHECK?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECSYS ANTI-TPO CALCHECK?

The FDA product code for ELECSYS ANTI-TPO 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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