Remel, Inc. - FDA 510(k) Cleared Devices

Cleared May 01, 2017

Remel Spectra ESBL

K162620 · JSO

Microbiology · 223d

Cleared Jul 12, 2013

REMEL XPECT FLU A&B

K131804 · GNX

Microbiology · 23d

Cleared Oct 08, 2010

REMEL SPECTRA MRSA

K092407 · JSO

Microbiology · 428d

Cleared Nov 26, 2007

RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE

K072827 · MJE

Microbiology · 54d

Cleared Nov 15, 2004

XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B

K041951 · LLH

Microbiology · 118d

Cleared Feb 26, 2004

PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY

K033479 · LLH

Microbiology · 115d

Cleared Nov 18, 2003

XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020

K031942 · MHI

Microbiology · 147d

Cleared Nov 14, 2003

XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020

K031965 · MHJ

Microbiology · 141d

Cleared Nov 10, 2003

XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY

K031834 · MHI

Microbiology · 150d

Cleared Jul 17, 2003

XPECT INFLUENZA A/B

K031565 · PSZ

Microbiology · 59d

Cleared Jul 14, 1998

PAR-ONE

K981391 · LIO

Microbiology · 88d

Cleared Apr 24, 1997

PYR SWAB

K970832 · JTO

Microbiology · 48d

Cleared Apr 17, 1997

GRAM SWAB

K970834 · JTO

Microbiology · 41d

Cleared Apr 02, 1997

REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK

K970830 · JTN

Microbiology · 26d

Cleared Apr 02, 1997

REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK

K970831 · JTN

Microbiology · 26d

Cleared Apr 02, 1997

INDOLE SWAB

K970833 · JTO

Microbiology · 26d

Cleared Sep 19, 1994

REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG

K935975 · JTN

Microbiology · 280d