Atlas FDA

TICARCILLIN 75MCG. SENSI-DISC

FDA 510(k) clearance K822832 · decided 1982-10-18

Clearance details

K-number
K822832
Device name
TICARCILLIN 75MCG. SENSI-DISC
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1982-09-21
Decision date
1982-10-18
Days to decision
27 days
Clearance type
Traditional
Product code
JTN
Device class
2
Regulation number
866.1620
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Washington, DC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BD Sensi-Disc Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 car recall (Z-0669-2007)Becton Dickinson & Co.2007-03-29

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