Cleared Traditional

FERRITIRON KIT CAT. #RP-1100

K800710 · Ria Products, Inc. · Immunology
May 1980
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K800710 is an FDA 510(k) clearance for the FERRITIRON KIT CAT. #RP-1100, a Radiometric, Fe59, Iron Binding Capacity (Class I — General Controls, product code JQG), submitted by Ria Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1980, 44 days after receiving the submission on March 31, 1980. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K800710 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1980
Decision Date May 14, 1980
Days to Decision 44 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JQG — Radiometric, Fe59, Iron Binding Capacity
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1415