Cleared Traditional

K770193 - PIPETTOR

K770193 is the FDA 510(k) clearance for PIPETTOR by Universal Instruments Corp.. It is a Class 1 Chemistry device (product code JQW) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K770193 · Universal Instruments Corp. · Chemistry device
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Mar 1977
Decision
32d
Days
Class 1
Risk

K770193 is an FDA 510(k) clearance for the PIPETTOR, 400, CENTRIFICHEM SYSTEM. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Universal Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1977 after a review of 32 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 Universal Instruments Corp. devices

Submission Details

510(k) Number K770193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1977
Decision Date March 01, 1977
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 65
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K770193.
PIPETTE, DISPENSING, MODEL ADP-30SD
K770772 · G.D. Searle and Co. · Jul 1977
PIPETTE, DILUTING, MODEL ADP-30SD
K770773 · G.D. Searle and Co. · Jul 1977
PIPETTOR W/DETIPPER
K770355 · Sherwood Medical Industries · Mar 1977
ANALYTIX AUTO SAMPLE PREP. STA. 1600
K770210 · G.D. Searle and Co. · Feb 1977