Cleared Traditional

K810949 - MRI PROLACTIN RIA KIT

K810949 is an FDA 510(k) clearance for MRI PROLACTIN RIA KIT, manufactured by Microanalytic Research, Inc.. The device is a Class 1 Immunology device with 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

FDA 510(k) Submission Details - K810949

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
11d faster than avg
Panel avg: 105d · This submission: 94d
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 K810949.
CENTRIA PROLACTIN TEST SET
K813572 · Ventrex Laboratories, Inc. · Mar 1982
LEECO PRL-QUANT DIAGNOSTIC TEST KIT
K820039 · Leeco Diagnostics, Inc. · Jan 1982
MARRIA-HPRL RIA KIT
K812112 · Intl. Immunoassay Laboratories, Inc. · Aug 1981
PROLACTIN (125) RADIOIMMUNAOASSAY
K803273 · Corning Medical & Scientific · Jan 1981
LACTI-QUANT
K801849 · Nuclear Medical Laboratories, Inc. · Sep 1980
GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-
K801020 · Travenol Laboratories, S.A. · Jul 1980