Cleared Traditional

K842390 - SYVA IQ 190 DIGITAL PIPETTER DILUTER

K842390 is an FDA 510(k) clearance for SYVA IQ 190 DIGITAL PIPETTER DILUTER, manufactured by Syva Co.. The device is a Class 1 Toxicology device with product code JQW cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K842390 · Syva Co. · Toxicology device
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Jul 1984
Decision
37d
Days
Class 1
Risk

K842390 is an FDA 510(k) clearance for the SYVA IQ 190 DIGITAL PIPETTER DILUTER. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on July 25, 1984 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2750 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K842390

510(k) Number K842390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1984
Decision Date July 25, 1984
Days to Decision 37 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 87d · This submission: 37d
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 139
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K842390.
LABOPETTOR
K843607 · Medical Technomics, Ltd. · Sep 1984
KEMBLE 405
K842894 · Kemble Instruments, Inc. · Aug 1984
FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP
K843073 · Greene International Corp. · Aug 1984
BEHRING ELISA PROCESSOR M
K841043 · Behring Diagnostics, Inc. · Jul 1984
HIGH SPEED DISPENSER
K840938 · Micromedic Systems · Apr 1984
ACCUFLEX
K834590 · Micromedic Systems · Mar 1984
K842390 · SYVA IQ 190 DIGITAL PIPETTER DILUTER
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