FDA 510(k)

KIDNEY, ARTIFICIAL

K-Number: K781153 · 1978-10-17

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1978-10-17

Product CodeDJC

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

KIDNEY, ARTIFICIAL is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1978-10-17 under 510(k) number K781153. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIDNEY, ARTIFICIAL?

KIDNEY, ARTIFICIAL is a medical device that received FDA 510(k) clearance on 1978-10-17. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K781153.

When did KIDNEY, ARTIFICIAL receive FDA 510(k) clearance?

KIDNEY, ARTIFICIAL received FDA 510(k) clearance on 1978-10-17, under 510(k) number K781153.

Who is the listed applicant for KIDNEY, ARTIFICIAL?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIDNEY, ARTIFICIAL?

The FDA product code for KIDNEY, ARTIFICIAL is DJC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.