Cleared Traditional

K832886 - FLAME PHOTOMETER T281-T282-T283

K832886 is an FDA 510(k) clearance for FLAME PHOTOMETER T281-T282-T283, manufactured by Texas Intl. Laboratories, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K832886

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.

JJO Device Classification - Class 1, General Controls

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 16
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