Cleared Traditional

K841712 - CAPILLARY GAS CHROMATOGRAPHIC COLUMNS
(FDA 510(k) Clearance)

May 1984
Decision
27d
Days
Class 1
Risk

K841712 is an FDA 510(k) clearance for the CAPILLARY GAS CHROMATOGRAPHIC COLUMNS. This device is classified as a Columns, Glc (Class I - General Controls, product code DII).

Submitted by Supelco, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1984, 27 days after receiving the submission on April 24, 1984.

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

Submission Details

510(k) Number K841712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1984
Decision Date May 21, 1984
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

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