MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC— 510(k) K983718

Clearance details

Applicant

Oxoid , Ltd.

Product code

Code JTN

Device class

Class 2

Regulation

21 CFR 866.1620

Advisory panel

Microbiology

Date received

1998-10-21

Decision date

1998-12-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Basingstoke, GB

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• Z-0734-2014 — Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.Class II·Terminated·Remel Inc·20131121

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983718.