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FDA 510(k)

5CM SMALL PARTS SCANNER

K-Number: K810914 · 1981-05-08

ApplicantSmithkline Diagnostics, Inc.
Decision Date1981-05-08
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

5CM SMALL PARTS SCANNER 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 1981-05-08 under 510(k) number K810914. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 5CM SMALL PARTS SCANNER?

5CM SMALL PARTS SCANNER is a medical device that received FDA 510(k) clearance on 1981-05-08. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K810914.

When did 5CM SMALL PARTS SCANNER receive FDA 510(k) clearance?

5CM SMALL PARTS SCANNER received FDA 510(k) clearance on 1981-05-08, under 510(k) number K810914.

Who is the listed applicant for 5CM SMALL PARTS SCANNER?

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 5CM SMALL PARTS SCANNER?

The FDA product code for 5CM SMALL PARTS SCANNER is IYO.

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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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