Cleared Traditional

DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER (K904783) - FDA 510(k) Clearance

Class I Chemistry device.

K904783 · Industrial Chemical Measurement · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 1991
Decision
178d
Days
Class 1
Risk

K904783 is an FDA 510(k) clearance for the DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Industrial Chemical Measurement (Hillsboro, US). The FDA issued a Cleared decision on April 18, 1991 after a review of 178 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 Industrial Chemical Measurement devices

Submission Details

510(k) Number K904783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1990
Decision Date April 18, 1991
Days to Decision 178 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 88d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 32
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K904783.
MICROTAK PLUS
K913840 · Syva Co. · Sep 1991
IMX SELECT ANALYZER
K912368 · Abbott Laboratories · Sep 1991
MICROTRAK MANAGER
K912959 · Syva Co. · Jul 1991
DU PONT VISTA(R) IMMUNOASSAY SYSTEM
K900245 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1990
NOVAPATH MICROPLATE READER
K900776 · Bio-Rad · Apr 1990
COBAS READY
K896007 · Roche Diagnostic Systems, Inc. · Dec 1989