Automated Immunoprecipitin Method/Iga

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K803274 ↗

FDA Product Code

CZP

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Automated Immunoprecipitin Method/Iga?

  The Automated Immunoprecipitin Method/Iga is an automated system designed for laboratory immunology testing. It is specifically used for the analysis of IgA, antigen, antiserum, and control components.

• What is the regulatory status of this device?

  This device is classified as a class 2 medical device under regulation number 866.5510. It has received FDA 510(k) clearance, identified by reference number K803274.

• How does the Automated Immunoprecipitin Method/Iga perform its analysis?

  The system utilizes immunoprecipitation techniques to facilitate the analysis of IgA and related components within a laboratory setting.