Cleared Traditional

K790440 - PROGESTERONE

K790440 is the FDA 510(k) clearance for PROGESTERONE by Serono Laboratories, Inc.. It is a Class 1 Chemistry device (product code JLS) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K790440 · Serono Laboratories, Inc. · Chemistry device
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May 1979
Decision
57d
Days
Class 1
Risk

K790440 is an FDA 510(k) clearance for the PROGESTERONE. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Serono Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1979 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1620 - the FDA in vitro diagnostics and chemistry framework. 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 Laboratories, Inc. devices

Submission Details

510(k) Number K790440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1979
Decision Date May 03, 1979
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JLS Radioimmunoassay, Progesterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1620
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.