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FDA 510(k)

FIDIS CONNECTIVE 10, MODEL MX006

K-Number: K053653 · 2006-03-13

ApplicantBiomedical Diagnostics (Bmd) SA
Decision Date2006-03-13
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIDIS CONNECTIVE 10, MODEL MX006 is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Diagnostics (Bmd) SA. It received FDA 510(k) clearance on 2006-03-13 under 510(k) number K053653. 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 FIDIS CONNECTIVE 10, MODEL MX006?

FIDIS CONNECTIVE 10, MODEL MX006 is a medical device that received FDA 510(k) clearance on 2006-03-13. The listed applicant is Biomedical Diagnostics (Bmd) SA. The 510(k) number is K053653.

When did FIDIS CONNECTIVE 10, MODEL MX006 receive FDA 510(k) clearance?

FIDIS CONNECTIVE 10, MODEL MX006 received FDA 510(k) clearance on 2006-03-13, under 510(k) number K053653.

Who is the listed applicant for FIDIS CONNECTIVE 10, MODEL MX006?

The FDA 510(k) record lists Biomedical Diagnostics (Bmd) SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIDIS CONNECTIVE 10, MODEL MX006?

The FDA product code for FIDIS CONNECTIVE 10, MODEL MX006 is LLL.

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Other records listing Biomedical Diagnostics (Bmd) SA 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.

K102607FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARISK100917FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEMK070458MODIFICATION TO FIDIS VASCULITIS, MODEL MX007K071210MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006K061794FIDIS TM THYRO, MODEL MX002K060380FIDIS DSDNA

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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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