Cleared Traditional

K782130 - MINI-DILUTER 2

K782130 is the FDA 510(k) clearance for MINI-DILUTER 2 by Dynatech Laboratories, Inc.. It is a Class 1 Chemistry device (product code JQW) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K782130 · Dynatech Laboratories, Inc. · Chemistry device
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Feb 1979
Decision
50d
Days
Class 1
Risk

K782130 is an FDA 510(k) clearance for the MINI-DILUTER 2. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Dynatech Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 15, 1979 after a review of 50 days - a notably fast clearance cycle.

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

View all Dynatech Laboratories, Inc. devices

Submission Details

510(k) Number K782130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date February 15, 1979
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 63
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K782130.
ACCUSTROKE PIPET
K800141 · Beckman Instruments, Inc. · Feb 1980
MICROMEDIC APS2
K791324 · Micromedic Systems · Aug 1979
ACCESSORY KIT, CENTRIFICHEM
K790041 · Union Carbide Corp. · Feb 1979
DILUTER, LSA 290 PIPETTER
K781883 · Kallestad Laboratories, Inc. · Dec 1978
AUTODILUTER 2
K781645 · Dynatech Laboratories, Inc. · Oct 1978
SRD-2
K781646 · Dynatech Laboratories, Inc. · Oct 1978