ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML— 510(k) K102668

Clearance details

Applicant

BIOMERIEUX

Product code

Code JWY

Device class

Class 2

Regulation

21 CFR 866.1640

Advisory panel

Microbiology

Date received

2010-09-16

Decision date

2010-11-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Craponne, FR

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102668.