Cleared Traditional

K851234 - A-JUST TURBIDITY METER

K851234 is an FDA 510(k) clearance for A-JUST TURBIDITY METER, manufactured by Abbott Laboratories. The device is a Class 1 Microbiology device with product code JQX cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K851234 · Abbott Laboratories · Microbiology device
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Apr 1985
Decision
34d
Days
Class 1
Risk

K851234 is an FDA 510(k) clearance for the A-JUST TURBIDITY METER. Classified as Nephelometer, For Clinical Use (product code JQX), Class I - General Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on April 29, 1985 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2700 - the FDA microbiology device 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K851234

510(k) Number K851234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1985
Decision Date April 29, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 102d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

JQX Device Classification - Class 1, General Controls

Product Code JQX Nephelometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2700
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 - JQX Nephelometer, For Clinical Use

All 11
Devices cleared under the same product code (JQX) and FDA review panel - the closest regulatory comparables to K851234.
ARRAY(R) 360
K922273 · Beckman Instruments, Inc. · Aug 1992
QMS(TM) - THEOPHYLLINE
K885263 · Seradyn, Inc. · Mar 1989
TDX ANALYZER W/NEPHELOMETRY CAROUSEL
K851253 · Abbott Laboratories · Apr 1985
ALBUMIN NEPHELOMETRIC ASSAY
K801362 · J.T. Baker Chemical Co. · Jul 1980
J.T. BAKER NEPHELOMETER
K801089 · J.T. Baker Chemical Co. · May 1980
NEPHELOMETER, MIC-2000 LASER
K790103 · Dynatech Corp. · Mar 1979