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FDA 510(k)

IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La

K-Number: K253817 · 2026-08-21

ApplicantImmunodiagnostics Systems Limited
Decision Date2026-08-21
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostics Systems Limited. It received FDA 510(k) clearance on 2026-08-21 under 510(k) number K253817. 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 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La?

IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Immunodiagnostics Systems Limited. The 510(k) number is K253817.

When did IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La receive FDA 510(k) clearance?

IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La received FDA 510(k) clearance on 2026-08-21, under 510(k) number K253817.

Who is the listed applicant for IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La?

The FDA 510(k) record lists Immunodiagnostics Systems Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La?

The FDA product code for IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La is LLL.

Related Devices (Code: LLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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