Cleared Traditional

K920419 - IL TEST DAT CAL/CONTROL SET D/E
(FDA 510(k) Clearance)

Mar 1992
Decision
40d
Days
Class 1
Risk

K920419 is an FDA 510(k) clearance for the IL TEST DAT CAL/CONTROL SET D/E. This device is classified as a Coating, Liquid, Glc (Class I - General Controls, product code DLG).

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on March 11, 1992, 40 days after receiving the submission on January 31, 1992.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2250.

Submission Details

510(k) Number K920419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1992
Decision Date March 11, 1992
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DLG — Coating, Liquid, Glc
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2250

Similar Devices — DLG Coating, Liquid, Glc

OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
K050988 · Lin-Zhi International, Inc. · Apr 2006
FPR AMIKACIN CALIBRATOR KIT
K894518 · Colony Laboratories, Inc. · Sep 1989
FPR GENTAMICIN CALIBRATOR KIT
K894524 · Colony Laboratories, Inc. · Sep 1989
FPR PHENYTOIN CALIBRATOR KIT
K894528 · Colony Laboratories, Inc. · Sep 1989
EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
K882766 · Em Diagnostic Systems, Inc. · Aug 1988
N-ACETYLPROCAINAMIDE CALIBRATOR
K833385 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983