Cleared Traditional

K810949 - MRI PROLACTIN RIA KIT

K810949 is the FDA 510(k) clearance for MRI PROLACTIN RIA KIT by Microanalytic Research, Inc.. It is a Class 1 Immunology device (product code CFT) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K810949 · Microanalytic Research, Inc. · Immunology device
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Jul 1981
Decision
94d
Days
Class 1
Risk

K810949 is an FDA 510(k) clearance for the MRI PROLACTIN RIA KIT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Microanalytic Research, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1625 - the FDA immunology device framework. 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 Microanalytic Research, Inc. devices

Submission Details

510(k) Number K810949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1981
Decision Date July 10, 1981
Days to Decision 94 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 104d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 50
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K810949.
PROLACTIN (125-I) RADIOIMMUNOASSAY KIT
K821305 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1982
CENTRIA PROLACTIN TEST SET
K813572 · Ventrex Laboratories, Inc. · Mar 1982
LEECO PRL-QUANT DIAGNOSTIC TEST KIT
K820039 · Leeco Diagnostics, Inc. · Jan 1982
PROLACTIN (125) RADIOIMMUNAOASSAY
K803273 · Corning Medical & Scientific · Jan 1981
GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-
K801020 · Travenol Laboratories, S.A. · Jul 1980
PROLACTIN RIA KIT
K800740 · Amersham Corp. · Apr 1980