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Prostate Specific Antigen (PSA) Calibrator

by Dade Chemistry Systems, Inc. 510(k)

Active United States

510(k) K973100

Overview

The Prostate Specific Antigen (PSA) Calibrator is an in vitro diagnostic product used to calibrate the Prostate Specific Antigen method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module. This calibrator is designed to ensure accurate results across the assay range of the PSA measurement method.

The device is supplied as a calibrator for clinical chemistry systems and is regulated under 21 CFR 862.1150. It is manufactured by Dade Chemistry Systems, Inc. and has FDA 510(k) clearance with the K973100 number. The device is intended for use in laboratory settings to calibrate PSA measurement methods.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK973100 Date29 Sep 1997ClearedStatusActive

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
JIT
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 PSA Calibrator used for?

    The PSA Calibrator is used to calibrate the Prostate Specific Antigen method for the Dimension RxL clinical chemistry system with the heterogeneous immunoassay module, ensuring accurate results across the assay range.

  • Is the PSA Calibrator supplied sterile?

    The description does not specify if the PSA Calibrator is supplied sterile, but it is intended for use in laboratory settings to calibrate PSA measurement methods.

  • What regulatory clearance does the PSA Calibrator have?

    The PSA Calibrator has FDA 510(k) clearance with the K973100 number, and is regulated under 21 CFR 862.1150.