Cleared Traditional

K801432 - HEMOPEXIN NEPHELOMETRIC ASSAY
(FDA 510(k) Clearance)

K801432 · J.T. Baker Chemical Co. · Immunology device
Jul 1980
Decision
20d
Days
Class 2
Risk

K801432 is an FDA 510(k) clearance for the HEMOPEXIN NEPHELOMETRIC ASSAY. This device is classified as a Hemopexin, Antigen, Antiserum, Control (Class II - Special Controls, product code CZX).

Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on July 8, 1980, 20 days after receiving the submission on June 18, 1980.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5490.

Submission Details

510(k) Number K801432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1980
Decision Date July 08, 1980
Days to Decision 20 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code CZX — Hemopexin, Antigen, Antiserum, Control
Device Class Class II - Special Controls
CFR Regulation 21 CFR 866.5490