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FDA 510(k)

CALCIJECT

K-Number: K001050 · 2000-07-21

ApplicantCentrix, Inc.
Decision Date2000-07-21
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CALCIJECT is the device name listed in this FDA 510(k) record. The listed applicant is Centrix, Inc.. It received FDA 510(k) clearance on 2000-07-21 under 510(k) number K001050. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALCIJECT?

CALCIJECT is a medical device that received FDA 510(k) clearance on 2000-07-21. The listed applicant is Centrix, Inc.. The 510(k) number is K001050.

When did CALCIJECT receive FDA 510(k) clearance?

CALCIJECT received FDA 510(k) clearance on 2000-07-21, under 510(k) number K001050.

Who is the listed applicant for CALCIJECT?

The FDA 510(k) record lists Centrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALCIJECT?

The FDA product code for CALCIJECT is EJK.

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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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