Cleared Traditional

K900599 - MICROPLATE REAGENT DISPENSER

K900599 is an FDA 510(k) clearance for MICROPLATE REAGENT DISPENSER, manufactured by Denley Instruments, Inc.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K900599 · Denley Instruments, Inc. · Chemistry device
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May 1990
Decision
98d
Days
Class 1
Risk

K900599 is an FDA 510(k) clearance for the MICROPLATE REAGENT DISPENSER. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Denley Instruments, Inc. (Bethesda, US). The FDA issued a Cleared decision on May 17, 1990 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - 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 Denley Instruments, Inc. devices

FDA 510(k) Submission Details - K900599

510(k) Number K900599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1990
Decision Date May 17, 1990
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 88d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 84
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K900599.
MARK 5 ROBOTIC PIPETTOR
K912228 · Diagnostic Products Corp. · Jun 1991
STRATUS(R) AUTOMATED SAMPLE HANDLER
K911712 · Baxter Healthcare Corp · May 1991
EPC ELECTRONIC PIPETTING SYSTEM
K902592 · Ulster Scientific, Inc. · Jul 1990
NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM
K900775 · Bio-Rad · Mar 1990
ABBOTT COMMANDER PARALLEL PROCESSING CENTER
K897158 · Abbott Laboratories · Mar 1990
DPC-ROBOSTAT(TM)
K894710 · Diagnostic Products Corp. · Aug 1989