Cleared Traditional

OCTAPETTES

K823137 · Corning Costar Corp. · Hematology
Dec 1982
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K823137 is an FDA 510(k) clearance for the OCTAPETTES, 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 December 3, 1982, 39 days after receiving the submission on October 25, 1982. This device falls under the Hematology review panel. Regulated under 21 CFR 866.2500.

Submission Details

510(k) Number K823137 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1982
Decision Date December 03, 1982
Days to Decision 39 days
Submission Type Traditional
Review Panel Hematology (HE)
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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