Cleared Traditional

CELL SCRAPER

K823138 · Corning Costar Corp. · Hematology
Nov 1982
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K823138 is an FDA 510(k) clearance for the CELL SCRAPER, a Flask, Tissue Culture (Class I — General Controls, product code KJA), submitted by Corning Costar Corp. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1982, 35 days after receiving the submission on October 25, 1982. This device falls under the Hematology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number K823138 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1982
Decision Date November 29, 1982
Days to Decision 35 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KJA — Flask, Tissue Culture
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2240

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