Cleared Traditional

MRI PROLACTIN RIA KIT

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

About This 510(k) Submission

K810949 is an FDA 510(k) clearance for the MRI PROLACTIN RIA KIT, a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Microanalytic Research, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981, 94 days after receiving the submission on April 7, 1981. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number K810949 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1981
Decision Date July 10, 1981
Days to Decision 94 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code CFT — Radioimmunoassay, Prolactin (lactogen)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1625

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