Cleared Traditional

AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)

K892362 · Amersham Corp. · Immunology
May 1989
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K892362 is an FDA 510(k) clearance for the AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL), a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on May 9, 1989, 33 days after receiving the submission on April 6, 1989. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K892362 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 1989
Decision Date May 09, 1989
Days to Decision 33 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DBF — Ferritin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5340

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