ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML— 510(k) K081325

Clearance details

Applicant

Ab Biodisk

Product code

Code JWY

Device class

Class 2

Regulation

21 CFR 866.1640

Advisory panel

Microbiology

Date received

2008-05-12

Decision date

2008-07-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Solna, SE

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081325.