Cleared Traditional

K790103 - NEPHELOMETER

K790103 is the FDA 510(k) clearance for NEPHELOMETER by Dynatech Corp.. It is a Class 1 Chemistry device (product code JQX) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K790103 · Dynatech Corp. · Chemistry device
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Mar 1979
Decision
55d
Days
Class 1
Risk

K790103 is an FDA 510(k) clearance for the NEPHELOMETER, MIC-2000 LASER. Classified as Nephelometer, For Clinical Use (product code JQX), Class I - General Controls.

Submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1979 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2700 - 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 Dynatech Corp. devices

Submission Details

510(k) Number K790103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1979
Decision Date March 12, 1979
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 10
Devices cleared under the same product code (JQX) and FDA review panel - the closest regulatory comparables to K790103.
A-JUST TURBIDITY METER
K851234 · 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
RAD-291
K781554 · Organon, Inc. · Oct 1978
NEPHELOMETER
K780251 · Kallestad Laboratories, Inc. · Apr 1978
LASER IMMUNONEPHELOMETRIC ANALYZER
K772361 · G.D. Searle and Co. · Jan 1978