Cleared Traditional

K842501 - TSS/FIK

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

FDA 510(k) Submission Details - K842501

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
154d slower than avg
Panel avg: 105d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -