Cleared Traditional

K902592 - EPC ELECTRONIC PIPETTING SYSTEM
(FDA 510(k) Clearance)

Jul 1990
Decision
37d
Days
Class 1
Risk

K902592 is an FDA 510(k) clearance for the EPC ELECTRONIC PIPETTING SYSTEM. This device is classified as a Station, Pipetting And Diluting, For Clinical Use (Class I - General Controls, product code JQW).

Submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on July 19, 1990, 37 days after receiving the submission on June 12, 1990.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K902592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1990
Decision Date July 19, 1990
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JQW — Station, Pipetting And Diluting, For Clinical Use
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2750

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