Cleared Traditional

BBLCRYSTAL ANAEROBE ID SYSTEM

K944528 · Becton Dickinson Microbiology Systems · Microbiology
Mar 1995
Decision
173d
Days
Class 1
Risk

About This 510(k) Submission

K944528 is an FDA 510(k) clearance for the BBLCRYSTAL ANAEROBE ID SYSTEM, a Kit, Anaerobic Identification (Class I — General Controls, product code JSP), submitted by Becton Dickinson Microbiology Systems (Cockeysville, US). The FDA issued a Cleared decision on March 7, 1995, 173 days after receiving the submission on September 15, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K944528 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1994
Decision Date March 07, 1995
Days to Decision 173 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JSP — Kit, Anaerobic Identification
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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