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FDA 510(k)

DIACELIN

K-Number: K840288 · 1984-04-23

ApplicantDiatech, Inc.
Decision Date1984-04-23
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIACELIN is the device name listed in this FDA 510(k) record. The listed applicant is Diatech, Inc.. It received FDA 510(k) clearance on 1984-04-23 under 510(k) number K840288. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIACELIN?

DIACELIN is a medical device that received FDA 510(k) clearance on 1984-04-23. The listed applicant is Diatech, Inc.. The 510(k) number is K840288.

When did DIACELIN receive FDA 510(k) clearance?

DIACELIN received FDA 510(k) clearance on 1984-04-23, under 510(k) number K840288.

Who is the listed applicant for DIACELIN?

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

What is the FDA product code for DIACELIN?

The FDA product code for DIACELIN is GGN.

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Other records listing Diatech, Inc. as applicant

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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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