Piperacilin Tazobactam 4 Ug

by Ab Biodisk Sweden(FDA 510(k) applicant) 510(k)

510(k) K953223 Product code JWY

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK953223	Date15 Aug 1995Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

4 recalls · FDA

4 recalls, same reason
- Terminated Z-0442-2016 FDA Class I initiated 19 Nov 2015
- Terminated Z-0439-2016 FDA Class I initiated 19 Nov 2015
- Terminated Z-0441-2016 FDA Class I initiated 19 Nov 2015
- Terminated Z-0440-2016 FDA Class I initiated 19 Nov 2015
Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.

Specification

510(k) · synced 11 Oct 2026

510(k) Number: K953223
FDA Product Code: JWY

Device Class: Class II
Regulation: 21 CFR Part 866.1640
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

Other devices from Ab Biodisk

System U3 for Tetracycline

Class II
ETEST Trovafloxacin

Class II
Etest Esbl CT/Ctl Strip; Etest Esbl Tz/Tzl Strip

Class II
Etest Vancomycin Open recall

Class II
Etest Submission for Cefotetan

Class II
Trimethoprim/Sulphamethoxazole

Class II

See all devices from Ab Biodisk →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K953223 24 fields · synced 11 Oct 2026