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FDA 510(k)

ANIT-ENA ANTIBODY TEST [SS-B (LA)]

K-Number: K920384 · 1992-03-30

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

Device Summary

ANIT-ENA ANTIBODY TEST [SS-B (LA)] 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 K920384. 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 ANIT-ENA ANTIBODY TEST [SS-B (LA)]?

ANIT-ENA ANTIBODY TEST [SS-B (LA)] 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 K920384.

When did ANIT-ENA ANTIBODY TEST [SS-B (LA)] receive FDA 510(k) clearance?

ANIT-ENA ANTIBODY TEST [SS-B (LA)] received FDA 510(k) clearance on 1992-03-30, under 510(k) number K920384.

Who is the listed applicant for ANIT-ENA ANTIBODY TEST [SS-B (LA)]?

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 ANIT-ENA ANTIBODY TEST [SS-B (LA)]?

The FDA product code for ANIT-ENA ANTIBODY TEST [SS-B (LA)] is LLL.

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Related Devices (Code: 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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