Cleared Traditional

BAC-T-SCREEN

K833917 · Marion Laboratories, Inc. · Chemistry
Jan 1984
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K833917 is an FDA 510(k) clearance for the BAC-T-SCREEN, a Monitor, Microbial Growth (Class I — General Controls, product code JTA), submitted by Marion Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984, 60 days after receiving the submission on November 14, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number K833917 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1983
Decision Date January 13, 1984
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JTA — Monitor, Microbial Growth
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2560

Similar Devices — JTA Monitor, Microbial Growth

All 10
BACTEC FUNGAL MEDIUM
K954923 · Becton Dickinson Diagnostic Instrument Systems · Nov 1996
BACTEC NR-860
K910835 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1991
BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM
K865021 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
BACTEC NR-730 BACTERIAL DETECTION SYSTEM
K853011 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1985
RADIOMETRIC BLOOD CULTURE VIALS, AEROBE
K842874 · American Micro Scan · Sep 1984
BECTEC NR-660 BACTERIAL DETECT SYS
K842279 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1984