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FDA 510(k)

MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006

K-Number: K071210 · 2007-12-19

ApplicantBiomedical Diagnostics (Bmd) SA
Decision Date2007-12-19
Product CodeLKO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO 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 2007-12-19 under 510(k) number K071210. The device is classified under product code LKO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006?

MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 is a medical device that received FDA 510(k) clearance on 2007-12-19. The listed applicant is Biomedical Diagnostics (Bmd) SA. The 510(k) number is K071210.

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

MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 received FDA 510(k) clearance on 2007-12-19, under 510(k) number K071210.

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

The FDA product code for MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 is LKO.

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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 MX007K061794FIDIS TM THYRO, MODEL MX002K060380FIDIS DSDNAK053383FIDIS CELIAC

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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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