Medical Device Manufacturer · US , Sparks , MD

Bd Diagnostic Systems - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2003

Recent clearances: BD BACTEC FXI Culture System, PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP), BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bd Diagnostic Systems Microbiology ✕

6 devices

1-6 of 6

Cleared May 28, 2026

BD BACTEC FXI Culture System

Microbiology · 125d

Cleared Sep 15, 2003

PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)

Microbiology · 32d

Cleared Sep 11, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML

Microbiology · 59d

Cleared Aug 19, 2003

PASCO MIC AND MIC/ID PANELS

Microbiology · 28d

Cleared Jun 06, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML

Microbiology · 31d

Cleared Feb 28, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML

Microbiology · 49d