Cleared Traditional

K873893 - LUMICON

K873893 is the FDA 510(k) clearance for LUMICON by Hamilton Co.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K873893 · Hamilton Co. · Chemistry device
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Jan 1988
Decision
104d
Days
Class 1
Risk

K873893 is an FDA 510(k) clearance for the LUMICON. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Hamilton Co. (Reno, US). The FDA issued a Cleared decision on January 5, 1988 after a review of 104 days - within the typical 510(k) review window.

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 Hamilton Co. devices

Submission Details

510(k) Number K873893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1987
Decision Date January 05, 1988
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
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 135
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K873893.
NOVASPEC II SPECTROPHOTOMETER
K883435 · Pharmacia, Inc. · Oct 1988
MODIFICATION OF BEHRING RAPIMAT II/T
K882095 · Behring Diagnostics, Inc. · Aug 1988
COBAS EIA(TM) PHOTOMETER
K881877 · Roche Diagnostic Systems, Inc. · Jun 1988
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
K873384 · Helena Laboratories · Nov 1987
DYNATECH MR 300 MANUAL MICROELISA
K874244 · Dynatech Laboratories, Inc. · Nov 1987
GEN-PROBE (R) LUMINOMETER - LEADER (TM)
K872219 · Gen-Probe, Inc. · Aug 1987