Atlas FDA

CEFTAZIDIME 30MCG. SENI-DISC

FDA 510(k) clearance K852873 · decided 1985-08-19

Clearance details

K-number
K852873
Device name
CEFTAZIDIME 30MCG. SENI-DISC
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1985-07-08
Decision date
1985-08-19
Days to decision
42 days
Clearance type
Traditional
Product code
JTN
Device class
2
Regulation number
866.1620
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Paramus, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility t recall (Z-1023-2024)Becton Dickinson & Co.2024-02-08

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