Cleared Traditional

K915896 - MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI

K915896 is an FDA 510(k) clearance for MICROLITE MICROTITER PLATE LUMINOMETER ..., manufactured by Dynatech Laboratories, Inc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 137-day FDA review.

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

FDA 510(k) Submission Details - K915896

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 88d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

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 165
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