BACTEC MGIT 960 SYSTEM— 510(k) K974883

Name: FDA 510(k) clearance K974883
Creator: U.S. Food and Drug Administration
Published: 1998-05-01

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K974883 for BACTEC MGIT 960 SYSTEM, Substantially Equivalent on 1998-05-01. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code MDB
Device class: Class 1
Regulation: 21 CFR 866.2560
Advisory panel: Microbiology
Date received: 1997-12-30
Decision date: 1998-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cockeysville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MDB

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K222559 — BD BACTEC Myco/F Lytic Culture Vials2023-03-24
K222591 — BD BACTEC Plus Aerobic/F Culture Vials2023-03-24
K190405 — BACT/ALERT MP Reagent System2019-05-15
K183166 — BacT/ALERT FA Plus; BacT/ALERT PF Plus2019-02-11

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K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE2001-02-01
K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/162000-11-29
K001364 — BD DIRECTIGEN FLU A+B2000-06-28

Adverse events under product code MDB

product code MDB

Death: 6
Malfunction: 5,490
Total: 5,496

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K974883

K-number listed on FDA's recall record

Z-0028-2014 — BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).Class II·Terminated·Becton Dickinson & Co.·20130909

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K974883.

Data sourced from openFDA. This site is unofficial and independent of the FDA.