Cleared Traditional

K834603 - TRANSFERRIN, ANTIGEN, ANTIBODY, CONTROL (FDA 510(k) Clearance)

K834603 · Technicon Instruments Corp. · Immunology device
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Jan 1984
Decision
122d
Days
-
Risk

K834603 is an FDA 510(k) clearance for the TRANSFERRIN, ANTIGEN, ANTIBODY, CONTROL.

Submitted by Technicon Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 122 days - within the typical 510(k) review window.

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

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K834603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1983
Decision Date January 30, 1984
Days to Decision 122 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 104d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -