Medical Device Manufacturer · US , Lenexa , KS

Remel, L.P.

10 submissions · 10 cleared · Since 1996
10
Total
10
Cleared
0
Denied

Remel, L.P. — FDA 510(k) Submissions

Remel, L.P. has submitted 10 FDA 510(k) premarket notifications since 1996, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Susceptibility Test Discs, Antimicrobial, Culture Media, Non-propagating Transport, Kit, Screening, Staphylococcus Aureus, Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar, Culture Media, For Isolation Of Pathogenic Neisseria . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
K972359 · JSO Culture Media,... · Microbiology
Aug 1997 64d
REMEL STAPH LATEX KIT
K964315 · JWX Kit, Screening,... · Microbiology
Feb 1997 101d
REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK
K964421 · JTN Susceptibility Test... · Microbiology
Dec 1996 66d
10B ARGININE BROTH
K961046 · JSM Culture Media,... · Microbiology
Sep 1996 187d
RPR LIQUID CONTROLS
K955143 · GMP Antisera, Control For... · Microbiology
Jul 1996 260d
RPR CARD TEST KIT
K955136 · GMQ Antigens, Nontreponemal, All · Microbiology
Jul 1996 259d
GENTAMICIN DISK (120MCG)
K961818 · JTN Susceptibility Test... · Microbiology
Jul 1996 61d
STREPTOMYCIN DISK (300MCG)
K961819 · JTN Susceptibility Test... · Microbiology
Jul 1996 61d
MUELLER HINTON AGAR WITH 2% NACI
K960313 · JTZ Culture Media,... · Microbiology
Mar 1996 63d
GC BASE W/ 1% GCHI
K954986 · JTY Culture Media, For... · Microbiology
Feb 1996 108d
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