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FDA 510(k)

SS-A/SS-B AUTOANTIBODY TEST SYSTEM

K-Number: K860644 · 1986-03-28

ApplicantImmuno Concepts, Inc.
Decision Date1986-03-28
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SS-A/SS-B AUTOANTIBODY TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Concepts, Inc.. It received FDA 510(k) clearance on 1986-03-28 under 510(k) number K860644. 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 SS-A/SS-B AUTOANTIBODY TEST SYSTEM?

SS-A/SS-B AUTOANTIBODY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1986-03-28. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K860644.

When did SS-A/SS-B AUTOANTIBODY TEST SYSTEM receive FDA 510(k) clearance?

SS-A/SS-B AUTOANTIBODY TEST SYSTEM received FDA 510(k) clearance on 1986-03-28, under 510(k) number K860644.

Who is the listed applicant for SS-A/SS-B AUTOANTIBODY TEST SYSTEM?

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

What is the FDA product code for SS-A/SS-B AUTOANTIBODY TEST SYSTEM?

The FDA product code for SS-A/SS-B AUTOANTIBODY TEST SYSTEM is LLL.

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Other records listing Immuno Concepts, Inc. as applicant

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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.

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK250408Alegria Flash ENA ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia AB

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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