Cleared Traditional

K832202 - PB 600 REPEATING DISPENSER

K832202 is the FDA 510(k) clearance for PB 600 REPEATING DISPENSER by Hamilton Co.. It is a Class 1 Chemistry device (product code JQW) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K832202 · Hamilton Co. · Chemistry device
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Aug 1983
Decision
48d
Days
Class 1
Risk

K832202 is an FDA 510(k) clearance for the PB 600 REPEATING DISPENSER. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Hamilton Co. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1983 after a review of 48 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 Hamilton Co. devices

Submission Details

510(k) Number K832202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1983
Decision Date August 24, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
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 K832202.
MICROLAB M DILUTER/DISPENSER
K833959 · Syva Co. · Jan 1984
IL MODEL 840 MICROPROCESSOR LOADER
K833505 · Instrumentation Laboratory CO · Jan 1984
ACCU-PREP PROGRAMMABLE AUTO-DILUTER
K832809 · Beckman Instruments, Inc. · Oct 1983
PRO QUANTUM
K831249 · Abbott Laboratories · Jul 1983
QST TM SAMPLE PROCESSOR
K831273 · Syva Co. · Jun 1983
DIGIFLEX AUTOMATIC PIPETTE
K830157 · Micromedic Systems · Mar 1983