Cleared Traditional

K915896 - MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI (FDA 510(k) Clearance)

Class I Chemistry device.

K915896 · Dynatech Laboratories, Inc. · Chemistry device
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May 1992
Decision
137d
Days
Class 1
Risk

K915896 is an FDA 510(k) clearance for the MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Dynatech Laboratories, Inc. (Chantilly, US). The FDA issued a Cleared decision on May 4, 1992 after a review of 137 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 Dynatech Laboratories, Inc. devices

Submission Details

510(k) Number K915896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1991
Decision Date May 04, 1992
Days to Decision 137 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 88d · This submission: 137d
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.