Cleared Traditional

K840530 - SUPPLIES FOR INSTRUMENTATION LAB FLAME

K840530 is the FDA 510(k) clearance for SUPPLIES FOR INSTRUMENTATION LAB FLAME by Shaban Mfg. Co.. It is a Class 1 Chemistry device (product code JJO) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K840530 · Shaban Mfg. Co. · Chemistry device
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Mar 1984
Decision
65d
Days
Class 1
Risk

K840530 is an FDA 510(k) clearance for the SUPPLIES FOR INSTRUMENTATION LAB FLAME. Classified as Flame Emission Photometer For Clinical Use (product code JJO), Class I - General Controls.

Submitted by Shaban Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1984 after a review of 65 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shaban Mfg. Co. devices

Submission Details

510(k) Number K840530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1984
Decision Date March 30, 1984
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 88d · This submission: 65d
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 11
Devices cleared under the same product code (JJO) and FDA review panel - the closest regulatory comparables to K840530.
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