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FDA 510(k)

LUPUS(LE)-LATEX TEST

K-Number: K905531 · 1991-01-25

ApplicantImmco Diagnostics, Inc.
Decision Date1991-01-25
Product CodeLKI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LUPUS(LE)-LATEX TEST is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-01-25 under 510(k) number K905531. 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 LUPUS(LE)-LATEX TEST?

LUPUS(LE)-LATEX TEST is a medical device that received FDA 510(k) clearance on 1991-01-25. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K905531.

When did LUPUS(LE)-LATEX TEST receive FDA 510(k) clearance?

LUPUS(LE)-LATEX TEST received FDA 510(k) clearance on 1991-01-25, under 510(k) number K905531.

Who is the listed applicant for LUPUS(LE)-LATEX TEST?

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

What is the FDA product code for LUPUS(LE)-LATEX TEST?

The FDA product code for LUPUS(LE)-LATEX TEST is LKI. This falls under the Chemistry category.

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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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