Atlas FDA

PIPERACILIN TAZOBACTAM 4 UG

FDA 510(k) clearance K953223 · decided 1995-08-15

Clearance details

K-number
K953223
Device name
PIPERACILIN TAZOBACTAM 4 UG
Applicant
Ab Biodisk
Decision
Substantially Equivalent
Date received
1995-04-14
Decision date
1995-08-15
Days to decision
123 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Solna, SE
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Etest Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest is a quanti recall (Z-0439-2016)Biomerieux2015-12-23
Etest PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest is a quantitative technique for d recall (Z-0440-2016)Biomerieux2015-12-23
Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest is a quantitative technique for recall (Z-0441-2016)Biomerieux2015-12-23
Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest is a quantitative technique for recall (Z-0442-2016)Biomerieux2015-12-23