Cleared Traditional

SPINSEP-FE59

K790133 · Nuclear Diagnostics, Inc. · Immunology
Mar 1979
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K790133 is an FDA 510(k) clearance for the SPINSEP-FE59, a Radiometric, Fe59, Iron Binding Capacity (Class I — General Controls, product code JQG), submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1979, 38 days after receiving the submission on January 23, 1979. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K790133 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 1979
Decision Date March 02, 1979
Days to Decision 38 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