FDA 510(k)

DIAMATIC, AUTOMATIC INSULIN INJECTOR

K-Number: K860284 · 1986-04-07

Decision Date1986-04-07

Product CodeKZH

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DIAMATIC, AUTOMATIC INSULIN INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Ulster Scientific, Inc.. It received FDA 510(k) clearance on 1986-04-07 under 510(k) number K860284. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAMATIC, AUTOMATIC INSULIN INJECTOR?

DIAMATIC, AUTOMATIC INSULIN INJECTOR is a medical device that received FDA 510(k) clearance on 1986-04-07. The listed applicant is Ulster Scientific, Inc.. The 510(k) number is K860284.

When did DIAMATIC, AUTOMATIC INSULIN INJECTOR receive FDA 510(k) clearance?

DIAMATIC, AUTOMATIC INSULIN INJECTOR received FDA 510(k) clearance on 1986-04-07, under 510(k) number K860284.

Who is the listed applicant for DIAMATIC, AUTOMATIC INSULIN INJECTOR?

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

What is the FDA product code for DIAMATIC, AUTOMATIC INSULIN INJECTOR?

The FDA product code for DIAMATIC, AUTOMATIC INSULIN INJECTOR is KZH.

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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.