Cleared Traditional

RADIOMETRIC BLOOD CULTURE VIALS, AEROBE

K842874 · American Micro Scan · Microbiology
Sep 1984
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K842874 is an FDA 510(k) clearance for the RADIOMETRIC BLOOD CULTURE VIALS, AEROBE, a Monitor, Microbial Growth (Class I — General Controls, product code JTA), submitted by American Micro Scan (Mchenry, US). The FDA issued a Cleared decision on September 12, 1984, 51 days after receiving the submission on July 23, 1984. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number K842874 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1984
Decision Date September 12, 1984
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
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
BECTEC NR-660 BACTERIAL DETECT SYS
K842279 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1984
BAC-T-SCREEN
K833917 · Marion Laboratories, Inc. · Jan 1984