Cleared Traditional

CENTRIFICHEM PIPETTOR 1000

K801851 · Union Carbide Corp. · Chemistry
Sep 1980
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K801851 is an FDA 510(k) clearance for the CENTRIFICHEM PIPETTOR 1000, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980, 43 days after receiving the submission on August 4, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K801851 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1980
Decision Date September 16, 1980
Days to Decision 43 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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