Cleared Traditional

K832886 - FLAME PHOTOMETER T281-T282-T283

K832886 is the FDA 510(k) clearance for FLAME PHOTOMETER T281-T282-T283 by Texas Intl. Laboratories, Inc.. It is a Class 1 Chemistry device (product code JJO) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K832886 · Texas Intl. Laboratories, Inc. · Chemistry device
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Dec 1983
Decision
104d
Days
Class 1
Risk

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

Submitted by Texas Intl. Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2540 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Texas Intl. Laboratories, Inc. devices

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJO Flame Emission Photometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJO Flame Emission Photometer For Clinical Use

All 12
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