Cleared Traditional

K891767 - GENETIC SYSTEMS MICROPLATE READER

K891767 is the FDA 510(k) clearance for GENETIC SYSTEMS MICROPLATE READER by Genetic Systems Corp.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K891767 · Genetic Systems Corp. · Chemistry device
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Jul 1989
Decision
123d
Days
Class 1
Risk

K891767 is an FDA 510(k) clearance for the GENETIC SYSTEMS MICROPLATE READER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Genetic Systems Corp. (Seattle, US). The FDA issued a Cleared decision on July 25, 1989 after a review of 123 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 Genetic Systems Corp. devices

Submission Details

510(k) Number K891767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1989
Decision Date July 25, 1989
Days to Decision 123 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 88d · This submission: 123d
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
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