NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC— 510(k) K964491

Clearance details

Applicant

Unipath , Ltd.

Product code

Code JTN

Device class

Class 2

Regulation

21 CFR 866.1620

Advisory panel

Microbiology

Date received

1996-11-07

Decision date

1997-02-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beverly, MA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964491.