Cleared Traditional

INNOFLUOR (TM) AMIKACIN CALIBRATOR SET

K903101 · Innotron of Oregon, Inc. · Toxicology
Aug 1990
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K903101 is an FDA 510(k) clearance for the INNOFLUOR (TM) AMIKACIN CALIBRATOR SET, a Calibrators, Drug Specific (Class II — Special Controls, product code DLJ), submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on August 22, 1990, 40 days after receiving the submission on July 13, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K903101 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1990
Decision Date August 22, 1990
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DLJ — Calibrators, Drug Specific
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

Similar Devices — DLJ Calibrators, Drug Specific

All 122
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
K132090 · Randox Laboratories, Ltd. · Aug 2013
QMS LIDOCAINE CALIBRATORS, MODEL 0374678
K091617 · Thermo Fisher Scientific · Jul 2009
DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
K082030 · Siemens Healthcare Diagnostics, Inc. · Aug 2008
DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
K062182 · Dade Behring, Inc. · Sep 2006
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
K062199 · Dade Behring, Inc. · Sep 2006
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
K061503 · Dade Behring, Inc. · Jun 2006