Cleared Traditional

MULTI-ACCESS REAGENT DISPENSER

K873416 · Electro-Nucleonics Laboratories, Inc. · Chemistry
Oct 1987
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K873416 is an FDA 510(k) clearance for the MULTI-ACCESS REAGENT DISPENSER, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Electro-Nucleonics Laboratories, Inc. (Columbia, US). The FDA issued a Cleared decision on October 9, 1987, 45 days after receiving the submission on August 25, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K873416 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 1987
Decision Date October 09, 1987
Days to Decision 45 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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