Medical Device Manufacturer · US , Lenexa , KS

Remel, Inc.

17 submissions · 17 cleared · Since 1994
17
Total
17
Cleared
0
Denied

Remel, Inc. — FDA 510(k) Submissions

Remel, Inc. has submitted 17 FDA 510(k) premarket notifications since 1994, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Susceptibility Test Discs, Antimicrobial, Discs, Strips And Reagents, Microorganism Differentiation, Giardia Spp., Reagents, Clostridium Difficile Toxin, Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
Remel Spectra ESBL
K162620 · JSO Culture Media,... · Microbiology
May 2017 223d
REMEL XPECT FLU A&B
K131804 · GNX Antigens, Cf (including... · Microbiology
Jul 2013 23d
REMEL SPECTRA MRSA
K092407 · JSO Culture Media,... · Microbiology
Oct 2010 428d
RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
K072827 · MJE Culture Media,... · Microbiology
Nov 2007 54d
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
K041951 · LLH Reagents, Clostridium... · Microbiology
Nov 2004 118d
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
K033479 · LLH Reagents, Clostridium... · Microbiology
Feb 2004 115d
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
K031942 · MHI Giardia Spp. · Microbiology
Nov 2003 147d
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
K031965 · MHJ Cryptosporidium Spp. · Microbiology
Nov 2003 141d
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
K031834 · MHI Giardia Spp. · Microbiology
Nov 2003 150d
XPECT INFLUENZA A/B
K031565 · PSZ Devices Detecting... · Microbiology
Jul 2003 59d
PAR-ONE
K981391 · LIO Device, Specimen Collection · Microbiology
Jul 1998 88d
PYR SWAB
K970832 · JTO Discs, Strips And... · Microbiology
Apr 1997 48d
GRAM SWAB
K970834 · JTO Discs, Strips And... · Microbiology
Apr 1997 41d
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK
K970830 · JTN Susceptibility Test... · Microbiology
Apr 1997 26d
REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
K970831 · JTN Susceptibility Test... · Microbiology
Apr 1997 26d
INDOLE SWAB
K970833 · JTO Discs, Strips And... · Microbiology
Apr 1997 26d
REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG
K935975 · JTN Susceptibility Test... · Microbiology
Sep 1994 280d
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