BACTEC MGIT 960 SIR KITS— 510(k) K003062

Name: FDA 510(k) clearance K003062
Creator: U.S. Food and Drug Administration
Published: 2001-06-06

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K003062 for BACTEC MGIT 960 SIR KITS, Substantially Equivalent on 2001-06-06. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code MJA
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2000-10-02
Decision date: 2001-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MJA

view all

K052323 — VERSATREK MYCO PZA KIT2006-01-19
K021582 — BACTEC MGIT 960 PZA KIT2002-07-13
K014123 — BACTEC MGIT 960 SIRE KITS2002-04-19
K972772 — ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING1999-07-13

More clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic

view all

K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2001-03-21
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
K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC2000-04-25

Adverse events under product code MJA

product code MJA

Malfunction: 827
Total: 827

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 →

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