Cleared Traditional

K823304 - RIASET PROLACTIN RIA KIT

K823304 is an FDA 510(k) clearance for RIASET PROLACTIN RIA KIT, manufactured by Immulok, Inc.. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K823304 · Immulok, Inc. · Chemistry device
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Dec 1982
Decision
47d
Days
Class 1
Risk

K823304 is an FDA 510(k) clearance for the RIASET PROLACTIN RIA KIT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1982 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1625 - 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 Immulok, Inc. devices

FDA 510(k) Submission Details - K823304

510(k) Number K823304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1982
Decision Date December 22, 1982
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

CFT Device Classification - Class 1, General Controls

Product Code CFT Radioimmunoassay, Prolactin (lactogen)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1625
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.

Regulatory Peers - CFT Radioimmunoassay, Prolactin (lactogen)

All 66
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K823304.
COAT-A-COUNT NHS-PROLACTIN KIT AND
K833925 · Diagnostic Products Corp. · Jan 1984
RIANEN PROLACTIN 125I KIT
K831345 · New England Nuclear · Jun 1983
RADIOIMMUNOASSAY TEST SYSTEM PRL
K830412 · Monobind · Apr 1983
ABBOTT LABORATORIES PROLACTIN EIA
K822759 · Abbott Laboratories · Oct 1982
TANDEM PROLACTIN KIT
K821545 · Hybritech, Inc. · Jun 1982
PROLACTIN (125-I) RADIOIMMUNOASSAY KIT
K821305 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1982