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FDA 510(k)

SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM

K-Number: K061879 · 2006-12-15

ApplicantHemodiagnostica, LLC
Decision Date2006-12-15
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hemodiagnostica, LLC. It received FDA 510(k) clearance on 2006-12-15 under 510(k) number K061879. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM?

SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-15. The listed applicant is Hemodiagnostica, LLC. The 510(k) number is K061879.

When did SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM receive FDA 510(k) clearance?

SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM received FDA 510(k) clearance on 2006-12-15, under 510(k) number K061879.

Who is the listed applicant for SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM?

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

What is the FDA product code for SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM?

The FDA product code for SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM is CFR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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