SYSTEM U3 FOR NITROFURANTOIN— 510(k) K983565

Substantially Equivalent

Ab Biodisk

FDA 510(k) clearance K983565 for SYSTEM U3 FOR NITROFURANTOIN, Substantially Equivalent on 1999-01-05. Applicant: Ab Biodisk.

Clearance details

Applicant: Ab Biodisk
Product code: Code JWY
Advisory panel: Microbiology
Date received: 1998-10-13
Decision date: 1999-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solna, SE

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