Cleared Traditional

AIR DISPLACEMENT PIPETTE

K885340 · Ulster Scientific, Inc. · Chemistry
Feb 1989
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K885340 is an FDA 510(k) clearance for the AIR DISPLACEMENT PIPETTE, 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 February 14, 1989, 48 days after receiving the submission on December 28, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K885340 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1988
Decision Date February 14, 1989
Days to Decision 48 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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