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FDA 510(k)

FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS

K-Number: K102607 · 2010-12-03

Decision Date2010-12-03
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS 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 2010-12-03 under 510(k) number K102607. 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 FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS?

FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is Biomedical Diagnostics (Bmd) SA. The 510(k) number is K102607.

When did FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS receive FDA 510(k) clearance?

FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS received FDA 510(k) clearance on 2010-12-03, under 510(k) number K102607.

Who is the listed applicant for FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS?

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 FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS?

The FDA product code for FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS is LLL.

Related Clinical Trials

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.

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.

View all 10 devices →

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.

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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