Cleared Traditional

K781883 - DILUTER

K781883 is the FDA 510(k) clearance for DILUTER by Kallestad Laboratories, Inc.. It is a Class 1 Chemistry device (product code JQW) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K781883 · Kallestad Laboratories, Inc. · Chemistry device
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Dec 1978
Decision
27d
Days
Class 1
Risk

K781883 is an FDA 510(k) clearance for the DILUTER, LSA 290 PIPETTER. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Kallestad Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on December 4, 1978 after a review of 27 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K781883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1978
Decision Date December 04, 1978
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 K781883.
MICROMEDIC APS2
K791324 · Micromedic Systems · Aug 1979
ACCESSORY KIT, CENTRIFICHEM
K790041 · Union Carbide Corp. · Feb 1979
MINI-DILUTER 2
K782130 · Dynatech Laboratories, Inc. · Feb 1979
AUTODILUTER 2
K781645 · Dynatech Laboratories, Inc. · Oct 1978
SRD-2
K781646 · Dynatech Laboratories, Inc. · Oct 1978
DILUTOR TRANSPORTER
K780785 · Hyland Therapeutic Div., Travenol Laboratories · Jun 1978