Cleared Traditional

MRI GENTAMICIN RIA KIT

K812394 · Microanalytic Research, Inc. · Microbiology
Sep 1981
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K812394 is an FDA 510(k) clearance for the MRI GENTAMICIN RIA KIT, a Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (Class II — Special Controls, product code DJB), submitted by Microanalytic Research, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 8, 1981, 19 days after receiving the submission on August 20, 1981. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K812394 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1981
Decision Date September 08, 1981
Days to Decision 19 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code DJB — Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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