MARTIN-LEWIS AGAR— 510(k) K830062

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code JTY

Device class

Class 2

Regulation

21 CFR 866.2410

Advisory panel

Microbiology

Date received

1983-01-11

Decision date

1983-02-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• K210511 — InTray GC2021-10-20
• K993033 — INTRAY GC1999-12-16
• K954986 — GC BASE W/ 1% GCHI1996-02-16
• K950196 — CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA1995-06-30
• K933122 — MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR1994-02-09

• K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System2026-07-08
• K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance2026-04-15
• K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)2025-08-21
• K234012 — VITEK COMPACT PRO2025-03-14
• K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)2024-06-12