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