Cleared Traditional

SERUM IRON/VIBC REAGENT SET

K852161 · Livonia Diagnostics, Inc. · Toxicology
Jun 1985
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K852161 is an FDA 510(k) clearance for the SERUM IRON/VIBC REAGENT SET, a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), submitted by Livonia Diagnostics, Inc. (Livonia, US). The FDA issued a Cleared decision on June 10, 1985, 21 days after receiving the submission on May 20, 1985. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number K852161 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1985
Decision Date June 10, 1985
Days to Decision 21 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code JIY — Photometric Method, Iron (non-heme)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1410

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