Cleared Traditional

K791324 - MICROMEDIC APS2

K791324 is the FDA 510(k) clearance for MICROMEDIC APS2 by Micromedic Systems. It is a Class 1 Chemistry device (product code JQW) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K791324 · Micromedic Systems · Chemistry device
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Aug 1979
Decision
43d
Days
Class 1
Risk

K791324 is an FDA 510(k) clearance for the MICROMEDIC APS2. 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 August 28, 1979 after a review of 43 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 K791324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1979
Decision Date August 28, 1979
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
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 K791324.
MICROMEDIC AUTOMATIC DILUTER
K800606 · Micromedic Systems · Apr 1980
MICROMEDIC PUNCH & ELUTER
K800075 · Micromedic Systems · Feb 1980
ACCUSTROKE PIPET
K800141 · Beckman Instruments, Inc. · Feb 1980
ACCESSORY KIT, CENTRIFICHEM
K790041 · Union Carbide Corp. · Feb 1979
MINI-DILUTER 2
K782130 · Dynatech Laboratories, Inc. · Feb 1979
DILUTER, LSA 290 PIPETTER
K781883 · Kallestad Laboratories, Inc. · Dec 1978