Cleared Traditional

GASTRIN RADIOIMMUNOASSAY TEST KIT (K842965) - FDA 510(k) Clearance

K842965 · Serono Diagnostics, Inc. · Chemistry device
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Oct 1984
Decision
76d
Days
-
Risk

K842965 is an FDA 510(k) clearance for the GASTRIN RADIOIMMUNOASSAY TEST KIT.

Submitted by Serono Diagnostics, Inc. (Bramtree, US). The FDA issued a Cleared decision on October 11, 1984 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Chemistry 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: 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 Serono Diagnostics, Inc. devices

Submission Details

510(k) Number K842965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1984
Decision Date October 11, 1984
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 88d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -