FDA 510(k)

IMMULOK CULTURESET

K-Number: K821567 · 1982-06-25

Decision Date1982-06-25

Product CodeGQL

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

IMMULOK CULTURESET is the device name listed in this FDA 510(k) record. The listed applicant is Immulok, Inc.. It received FDA 510(k) clearance on 1982-06-25 under 510(k) number K821567. The device is classified under product code GQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULOK CULTURESET?

IMMULOK CULTURESET is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is Immulok, Inc.. The 510(k) number is K821567.

When did IMMULOK CULTURESET receive FDA 510(k) clearance?

IMMULOK CULTURESET received FDA 510(k) clearance on 1982-06-25, under 510(k) number K821567.

Who is the listed applicant for IMMULOK CULTURESET?

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

What is the FDA product code for IMMULOK CULTURESET?

The FDA product code for IMMULOK CULTURESET is GQL.

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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.