Cleared Traditional

K840530 - SUPPLIES FOR INSTRUMENTATION LAB FLAME

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

K840530 · Shaban Mfg. Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K840530

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.

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 15
Devices cleared under the same product code (JJO) and FDA review panel - the closest regulatory comparables to K840530.
LITHIUM REAGENT
K841847 · Reagent Laboratory, Inc. · Aug 1984
DAILY WASH SOLUTION 5
K841421 · Reagent Laboratory, Inc. · May 1984
VOLUME TEST DYE 6
K841422 · Reagent Laboratory, Inc. · May 1984
POTASSIUM SODIUM ANALYSIS PRODUCTS
K833535 · Shaban Mfg. Co. · Dec 1983
SHABAN #9852 CHIMNEY-#9854 SCREEN &
K832931 · Shaban Mfg. Co. · Oct 1983
SHABAN #9858 ASPIRATOR ASSEMBLE #9862-
K832932 · Shaban Mfg. Co. · Oct 1983