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SDI CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System

by Hemodiagnostica, LLC

510(k) K061879

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061879 Date15 Dec 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CFR
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SDI CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System is a discrete, random access, microprocessor controlled clinical chemistry analyzer intended for in vitro diagnostic quantitative measurement of Glucose, Blood Urea Nitrogen (BUN), Sodium, Potassium and Chloride in serum. It includes dedicated reagents for these measurements.

The device is supplied with dedicated reagents and is intended for use in clinical laboratory settings. It received FDA 510(k) clearance (K061879) on December 15, 2006, and is classified as a Class II device under regulation number 862.1345 with product code CFR.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SDI CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System intended to measure?

    The system is intended for in vitro diagnostic quantitative measurement of Glucose, Blood Urea Nitrogen (BUN), Sodium, Potassium, and Chloride in serum samples. It is a discrete, random access, microprocessor-controlled clinical chemistry analyzer that includes dedicated reagents for these specific analytes, as stated in the device description.

  • How is the SDI CA480 Clinical Chemistry System supplied and what does it include?

    The device is supplied with dedicated reagents for the measurement of Glucose, BUN, Sodium, Potassium, and Chloride in serum. It is intended for use in clinical laboratory settings and includes the analyzer and its associated reagents as part of the system, as specified in the device description.

  • What regulatory pathway was used for the SDI CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System?

    The device received FDA 510(k) clearance under submission number K061879 on December 15, 2006, and was determined to be substantially equivalent to a predicate device. This information is explicitly stated in the AUTHORIZATIONS and SPECIFICATIONS sections of the device data.

  • What is the classification and regulation number for the SDI CA480 Clinical Chemistry System?

    The device is classified as a Class II medical device under regulation number 862.1345, with product code CFR, as indicated in the SPECIFICATIONS section under regulation_number and device_class=2. This classification reflects its regulatory grouping for clinical chemistry analyzers.

  • Who is the manufacturer of the SDI CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System?

    The manufacturer of the device is Hemodiagnostica, LLC, as listed in the MANUFACTURER field and confirmed in the applicant and contact fields within the SPECIFICATIONS section, which also provides their address in Johns Island, SC.