Cleared Traditional

K790250 - LIQUISOL CORTISOL RIA TEST KIT (FDA 510(k) Clearance)

K790250 · Damon Corp. · Toxicology device
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Apr 1979
Decision
57d
Days
-
Risk

K790250 is an FDA 510(k) clearance for the LIQUISOL CORTISOL RIA TEST KIT.

Submitted by Damon Corp. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1979 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Toxicology 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 Damon Corp. devices

Submission Details

510(k) Number K790250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1979
Decision Date April 04, 1979
Days to Decision 57 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 87d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -