Cleared Traditional

K790133 - SPINSEP-FE59 (FDA 510(k) Clearance)

Class I Immunology device.

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

K790133 is an FDA 510(k) clearance for the SPINSEP-FE59. Classified as Radiometric, Fe59, Iron Binding Capacity (product code JQG), Class I - General Controls.

Submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1979 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1415 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nuclear Diagnostics, Inc. devices

Submission Details

510(k) Number K790133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1979
Decision Date March 02, 1979
Days to Decision 38 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 104d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQG Radiometric, Fe59, Iron Binding Capacity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1415
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.