Cleared Traditional

K862542 - CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY
(FDA 510(k) Clearance)

Aug 1986
Decision
32d
Days
Class 1
Risk

K862542 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 August 4, 1986, 32 days after receiving the submission on July 3, 1986.

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

Submission Details

510(k) Number K862542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1986
Decision Date August 04, 1986
Days to Decision 32 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