FDA 510(k)

CULUTURE SET CHLAMYDIA ISOLATION AND

K-Number: K830342 · 1983-05-04

Decision Date1983-05-04

Product CodeLKI

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

CULUTURE SET CHLAMYDIA ISOLATION AND is the device name listed in this FDA 510(k) record. The listed applicant is Immulok, Inc.. It received FDA 510(k) clearance on 1983-05-04 under 510(k) number K830342. The device is classified under product code LKI. It was reviewed by the MI advisory panel. Product code LKI falls under the category of Chemistry, which covers automated chemistry analyzers and related reagents. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CULUTURE SET CHLAMYDIA ISOLATION AND?

CULUTURE SET CHLAMYDIA ISOLATION AND is a medical device that received FDA 510(k) clearance on 1983-05-04. The listed applicant is Immulok, Inc.. The 510(k) number is K830342.

When did CULUTURE SET CHLAMYDIA ISOLATION AND receive FDA 510(k) clearance?

CULUTURE SET CHLAMYDIA ISOLATION AND received FDA 510(k) clearance on 1983-05-04, under 510(k) number K830342.

Who is the listed applicant for CULUTURE SET CHLAMYDIA ISOLATION AND?

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 CULUTURE SET CHLAMYDIA ISOLATION AND?

The FDA product code for CULUTURE SET CHLAMYDIA ISOLATION AND is LKI. This falls under the Chemistry category.

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Related Devices (Code: LKI)

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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.