Atlas FDA

BACTEC MGIT 960 SYSTEM

FDA 510(k) clearance K974883 · decided 1998-05-01

Clearance details

K-number
K974883
Device name
BACTEC MGIT 960 SYSTEM
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1997-12-30
Decision date
1998-05-01
Days to decision
122 days
Clearance type
Traditional
Product code
MDB
Device class
1
Regulation number
866.2560
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Cockeysville, MD, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct c recall (Z-0028-2014)Becton Dickinson & Co.2013-10-19
BD BACTEC(tm) MGI (tm) System Software, Catalog 445922, Lot V5.02A. Product Usage: The BAC recall (Z-2890-2011)Becton Dickinson & Co.2011-07-28

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