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Syva Advance Standardization Kit 01

by Syva Co. 510(k)

Active United States

510(k) K820698

Overview

The Syva Advance Standardization Kit 01 is a primary calibrator device used in clinical chemistry laboratories. It is designed to standardize laboratory testing procedures by providing reference materials for calibrating analytical instruments.

This device is supplied as a kit and is intended for single-use in laboratory settings. It is classified as a Class II medical device under regulation 862.1150 and received FDA 510(k) clearance on April 1, 1982, with the K number K820698. The device is manufactured by Syva Co. and is not indicated for MRI use.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820698 Date1 Apr 1982ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JIS
Device Class
Class II
Regulation
21 CFR Part 862.1150
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Syva Advance Standardization Kit 01 used for?

    The Syva Advance Standardization Kit 01 is a primary calibrator device used in clinical chemistry laboratories to standardize laboratory testing procedures by providing reference materials for calibrating analytical instruments.

  • How is the Syva Advance Standardization Kit 01 supplied and is it reusable?

    The device is supplied as a kit and is intended for single-use in laboratory settings. It should not be reused as it is designed for one-time calibration procedures.

  • What is the regulatory classification and clearance status of this device?

    The Syva Advance Standardization Kit 01 is classified as a Class II medical device under regulation 862.1150 and received FDA 510(k) clearance on April 1, 1982, with the K number K820698.

  • Is the Syva Advance Standardization Kit 01 suitable for MRI use?

    No, the device is not indicated for MRI use. It is specifically designed for standardizing laboratory testing procedures in clinical chemistry settings.