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FDA 510(k)

ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST

K-Number: K895339 · 1989-10-04

ApplicantImmco Diagnostics, Inc.
Decision Date1989-10-04
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY 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 1989-10-04 under 510(k) number K895339. 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-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST?

ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1989-10-04. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K895339.

When did ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST receive FDA 510(k) clearance?

ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST received FDA 510(k) clearance on 1989-10-04, under 510(k) number K895339.

Who is the listed applicant for ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY 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 ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST?

The FDA product code for ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST 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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