Cleared Traditional

MRI TOBRAMYCIN RIA KIT

K813516 · Microanalytic Research, Inc. · Microbiology
Dec 1981
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K813516 is an FDA 510(k) clearance for the MRI TOBRAMYCIN RIA KIT, a Radioimmunoassay, Tobramycin (Class II — Special Controls, product code KLB), submitted by Microanalytic Research, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 29, 1981, 14 days after receiving the submission on December 15, 1981. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K813516 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1981
Decision Date December 29, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code KLB — Radioimmunoassay, Tobramycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3900

Similar Devices — KLB Radioimmunoassay, Tobramycin

All 22
ONLINE TDM TOBRAMYCIN
K060853 · Roche Diagnostics Corp. · Jun 2006
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
K012312 · Diagnostic Products Corp. · Aug 2001
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
K003341 · Syva Co., Dade Behring, Inc. · Jan 2001
DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD
K904304 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990
IL TOBRAMYCIN ASSAY
K903192 · Instrumentation Laboratory CO · Aug 1990
TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD
K893913 · Technicon Instruments Corp. · Aug 1989