Cleared Traditional

TSS/FIK (K842501) - FDA 510(k) Clearance

K842501 · Zarcon Corp. · Immunology device
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Mar 1985
Decision
259d
Days
-
Risk

K842501 is an FDA 510(k) clearance for the TSS/FIK.

Submitted by Zarcon Corp. (Berkeley, US). The FDA issued a Cleared decision on March 12, 1985 after a review of 259 days - an extended review cycle.

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.

View all Zarcon Corp. devices

Submission Details

510(k) Number K842501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1984
Decision Date March 12, 1985
Days to Decision 259 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 104d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -