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FDA 510(k)

SKI 5000

K-Number: K812646 · 1981-11-16

ApplicantSmithkline Diagnostics, Inc.
Decision Date1981-11-16
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SKI 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812646. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKI 5000?

SKI 5000 is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K812646.

When did SKI 5000 receive FDA 510(k) clearance?

SKI 5000 received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812646.

Who is the listed applicant for SKI 5000?

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

What is the FDA product code for SKI 5000?

The FDA product code for SKI 5000 is DXK.

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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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