Atlas FDA

BACTEC 9120 SYSTEM

FDA 510(k) clearance K922475 · decided 1992-07-01

Clearance details

K-number
K922475
Device name
BACTEC 9120 SYSTEM
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1992-05-26
Decision date
1992-07-01
Days to decision
36 days
Clearance type
Traditional
Product code
MDB
Device class
1
Regulation number
866.2560
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Franklin Lakes, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog N recall (Z-0237-2026)Becton Dickinson & Co.2025-10-23
BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570 recall (Z-0595-2025)Becton Dickinson & Co.2024-12-03

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05