Cleared Traditional

K800606 - MICROMEDIC AUTOMATIC DILUTER

K800606 is the FDA 510(k) clearance for MICROMEDIC AUTOMATIC DILUTER by Micromedic Systems. It is a Class 1 Chemistry device (product code JQW) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K800606 · Micromedic Systems · Chemistry device
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Apr 1980
Decision
30d
Days
Class 1
Risk

K800606 is an FDA 510(k) clearance for the MICROMEDIC AUTOMATIC DILUTER. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Micromedic Systems (Mchenry, US). The FDA issued a Cleared decision on April 16, 1980 after a review of 30 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 Micromedic Systems devices

Submission Details

510(k) Number K800606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1980
Decision Date April 16, 1980
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
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 64
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K800606.
CENTRIFICHEM PIPETTOR 1000
K801851 · Union Carbide Corp. · Sep 1980
J.T. BAKER LSA 290 PIPETTER/DILUTER
K801090 · J.T. Baker Chemical Co. · Jun 1980
RIAUSE AUTO PROCESSOR
K801030 · Electro-Nucleonics Laboratories, Inc. · May 1980
MICROMEDIC PUNCH & ELUTER
K800075 · Micromedic Systems · Feb 1980
ACCUSTROKE PIPET
K800141 · Beckman Instruments, Inc. · Feb 1980
MICROMEDIC APS2
K791324 · Micromedic Systems · Aug 1979