Cleared Traditional

ADJUSTABLE DISPENSOR

K780912 · Oxford Laboratories, Inc. · Chemistry
Jun 1978
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K780912 is an FDA 510(k) clearance for the ADJUSTABLE DISPENSOR, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Oxford Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1978, 23 days after receiving the submission on June 5, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K780912 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1978
Decision Date June 28, 1978
Days to Decision 23 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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