Cleared Traditional

K832886 - FLAME PHOTOMETER T281-T282-T283
(FDA 510(k) Clearance)

Dec 1983
Decision
104d
Days
Class 1
Risk

K832886 is an FDA 510(k) clearance for the FLAME PHOTOMETER T281-T282-T283. This device is classified as a Flame Emission Photometer For Clinical Use (Class I - General Controls, product code JJO).

Submitted by Texas Intl. Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983, 104 days after receiving the submission on August 26, 1983.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2540.

Submission Details

510(k) Number K832886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1983
Decision Date December 08, 1983
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JJO — Flame Emission Photometer For Clinical Use
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2540