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FDA 510(k)

ANTI-ENA ANTIBODY TEST KIT

K-Number: K920386 · 1992-03-30

ApplicantImmco Diagnostics, Inc.
Decision Date1992-03-30
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-ENA ANTIBODY TEST KIT 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 1992-03-30 under 510(k) number K920386. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-ENA ANTIBODY TEST KIT?

ANTI-ENA ANTIBODY TEST KIT is a medical device that received FDA 510(k) clearance on 1992-03-30. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K920386.

When did ANTI-ENA ANTIBODY TEST KIT receive FDA 510(k) clearance?

ANTI-ENA ANTIBODY TEST KIT received FDA 510(k) clearance on 1992-03-30, under 510(k) number K920386.

Who is the listed applicant for ANTI-ENA ANTIBODY TEST KIT?

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 ANTI-ENA ANTIBODY TEST KIT?

The FDA product code for ANTI-ENA ANTIBODY TEST KIT is LLL.

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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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