Cleared Traditional

K781769 - IRON 59 KIT
(FDA 510(k) Clearance)

K781769 · Ria Products, Inc. · Chemistry device
Dec 1978
Decision
49d
Days
Class 1
Risk

K781769 is an FDA 510(k) clearance for the IRON 59 KIT. This device is classified as a Radio-labeled Iron Method, Iron (non-heme) (Class I - General Controls, product code JJA).

Submitted by Ria Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978, 49 days after receiving the submission on October 16, 1978.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number K781769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1978
Decision Date December 04, 1978
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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