SERACON-SRII

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

510(k) Number

K781758 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Seracon-Sri (Prod. # D029

  Class II

  FDA 510(k) K792486 Active Cleared 31 Dec 1979

• Seracon Cal D025

  Class II

  FDA 510(k) K791956 Active Cleared 11 Oct 1979

• Quanticel Hhr + Two Human Hematology W/Platelets

  Class II

  FDA 510(k) K844927 Active Cleared 22 Mar 1985

• Seracon Tm Sr III

  Class II

  FDA 510(k) K844027 Active Cleared 27 Nov 1984

• Quanticel Hhr, L531 and L532

  Class II

  FDA 510(k) K781745 Active Cleared 15 Nov 1978

• Quanticel Hhr Two Human Hematology Reference

  Class II

  FDA 510(k) K844928 Active Cleared 22 Mar 1985

See all devices from Bhp Diagnostix, Inc. →

• What is the SERACON-SRII used for in clinical settings?

  The SERACON-SRII is a calibrator and multi-analyte mixture designed to provide reference values for various analytes in clinical chemistry testing, ensuring accurate laboratory results.

• How is the SERACON-SRII supplied and what is its regulatory status?

  The SERACON-SRII is supplied by Bhp Diagnostix, Inc. and is authorized under FDA 510K clearance K781758. It is a Class II medical device regulated under product code JIX and regulation number 862.1150.

• Is the SERACON-SRII a single-use device or can it be reused?

  The device data does not specify whether the SERACON-SRII is single-use or reusable. Users should refer to the manufacturer's instructions for proper handling and usage guidelines.

• What are the storage requirements for the SERACON-SRII?

  The device data does not include specific storage requirements. Users should consult the manufacturer's documentation for proper storage conditions to maintain the calibrator's integrity and performance.