Cleared Traditional

K874824 - CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY
(FDA 510(k) Clearance)

Jan 1988
Decision
58d
Days
Class 1
Risk

K874824 is an FDA 510(k) clearance for the CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY. This device is classified as a Columns, Glc (Class I - General Controls, product code DII).

Submitted by Supelco, Inc. (Bellefonte, US). The FDA issued a Cleared decision on January 21, 1988, 58 days after receiving the submission on November 24, 1987.

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

Submission Details

510(k) Number K874824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1987
Decision Date January 21, 1988
Days to Decision 58 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary

Device Classification

Product Code DII — Columns, Glc
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2250