Cleared Traditional

SEROCLUSTER U AND V

K800240 · Corning Costar Corp. · Microbiology
Feb 1980
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K800240 is an FDA 510(k) clearance for the SEROCLUSTER U AND V, a Device, Microtiter Diluting/dispensing (Class I — General Controls, product code JTC), submitted by Corning Costar Corp. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980, 8 days after receiving the submission on February 5, 1980. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2500.

Submission Details

510(k) Number K800240 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 1980
Decision Date February 13, 1980
Days to Decision 8 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTC — Device, Microtiter Diluting/dispensing
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2500

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