MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS— 510(k) K850291

Clearance details

Applicant

Remel Co.

Product code

Code JTZ

Device class

Class 2

Regulation

21 CFR 866.1700

Advisory panel

Microbiology

Date received

1985-01-24

Decision date

1985-05-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lenexa, KS, US

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• K013711 — BACTI-SWAB DRY2001-11-26
• K965149 — A.C.T. I1997-01-22
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• Z-2137-2018 — remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).Class II·Terminated·Thermo Fisher·20180504

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K850291.