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FDA 510(k)

RHIGENE MESACUP2 TEST- SSA

K-Number: K000749 · 2000-05-09

ApplicantRhigene, Inc.
Decision Date2000-05-09
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHIGENE MESACUP2 TEST- SSA is the device name listed in this FDA 510(k) record. The listed applicant is Rhigene, Inc.. It received FDA 510(k) clearance on 2000-05-09 under 510(k) number K000749. 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 RHIGENE MESACUP2 TEST- SSA?

RHIGENE MESACUP2 TEST- SSA is a medical device that received FDA 510(k) clearance on 2000-05-09. The listed applicant is Rhigene, Inc.. The 510(k) number is K000749.

When did RHIGENE MESACUP2 TEST- SSA receive FDA 510(k) clearance?

RHIGENE MESACUP2 TEST- SSA received FDA 510(k) clearance on 2000-05-09, under 510(k) number K000749.

Who is the listed applicant for RHIGENE MESACUP2 TEST- SSA?

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

What is the FDA product code for RHIGENE MESACUP2 TEST- SSA?

The FDA product code for RHIGENE MESACUP2 TEST- SSA is LLL.

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Other records listing Rhigene, Inc. as applicant

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.

K040711MESACUP TEST PR-3K040586MESACUP TEST MPO, MODEL 11053K040200MESACUP-2 TEST CENP-BK033528MESACUP-2 TEST JO-1, MODEL 10756K031308RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760K022017RHIGENE MESACUP-2 TEST RNP, MODEL M7741

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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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