Cleared Traditional

CELL SCRAPER

K885121 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Pathology
Dec 1988
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K885121 is an FDA 510(k) clearance for the CELL SCRAPER, a Flask, Tissue Culture (Class I — General Controls, product code KJA), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 28, 1988, 16 days after receiving the submission on December 12, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number K885121 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1988
Decision Date December 28, 1988
Days to Decision 16 days
Submission Type Traditional
Review Panel Pathology (PA)
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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