Cleared Traditional

K832962 - GAS CHROMATOGRAPH 5890A
(FDA 510(k) Clearance)

Oct 1983
Decision
59d
Days
Class 1
Risk

K832962 is an FDA 510(k) clearance for the GAS CHROMATOGRAPH 5890A. This device is classified as a Chromatography(gas), Clinical Use (Class I - General Controls, product code KZQ).

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983, 59 days after receiving the submission on August 30, 1983.

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

Submission Details

510(k) Number K832962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1983
Decision Date October 28, 1983
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code KZQ — Chromatography(gas), Clinical Use
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2250

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