ETEST FOSFOMYCIN— 510(k) K981136

Clearance details

Applicant

Ab Biodisk

Product code

Code JWY

Device class

Class 2

Regulation

21 CFR 866.1640

Advisory panel

Microbiology

Date received

1998-03-30

Decision date

1998-06-09

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 K981136.