Home / 510(k) Clearances / K021582

510(k) K021582

BACTEC MGIT 960 PZA KIT by Becton, Dickinson & CO — Product Code MJA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2002
Date Received
May 14, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Powders, Antimycobacterial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Becton, Dickinson & CO

  • K252040 — BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Bloo (March 13, 2026)
  • K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (December 2, 2025)
  • K250358 — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus fo (October 31, 2025)
  • K250059 — BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) (September 12, 2025)
  • K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (August 8, 2025)
  • K251350 — BD Plastipak™ Syringe (July 29, 2025)
  • K243207 — BD Vacutainer® Eclipse™ Blood Collection Needle (July 3, 2025)
  • K243872 — BD Veritor System for SARS-CoV-2 (June 16, 2025)
  • K250447 — BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 1 (May 19, 2025)
  • K243649 — BD Vacutainer® Multiple Sample Luer Adapter (March 21, 2025)

Other clearances for product code MJA

  • K052323 — VERSATREK MYCO PZA KIT (January 19, 2006)
  • K014123 — BACTEC MGIT 960 SIRE KITS (April 19, 2002)
  • K003062 — BACTEC MGIT 960 SIR KITS (June 6, 2001)
  • K972772 — ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING (July 13, 1999)