Medical Device Manufacturer · US , Lenexa , KS

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

17 submissions · 17 cleared · Since 1994

Recent clearances: Remel Spectra ESBL, REMEL XPECT FLU A&B, REMEL SPECTRA MRSA

View 17 510(k) Devices ↓

17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Remel, Inc. Microbiology ✕

17 devices

1-12 of 17

Cleared May 01, 2017

Remel Spectra ESBL

Microbiology · 223d

Cleared Jul 12, 2013

REMEL XPECT FLU A&B

Microbiology · 23d

Cleared Oct 08, 2010

REMEL SPECTRA MRSA

Microbiology · 428d

Cleared Nov 26, 2007

RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE

Microbiology · 54d

Cleared Nov 15, 2004

XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B

Microbiology · 118d

Cleared Feb 26, 2004

PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY

Microbiology · 115d

Cleared Nov 18, 2003

XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020

Microbiology · 147d

Cleared Nov 14, 2003

XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020

Microbiology · 141d

Cleared Nov 10, 2003

XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY

Microbiology · 150d

Cleared Jul 17, 2003

XPECT INFLUENZA A/B

Microbiology · 59d

Cleared Jul 14, 1998

Microbiology · 88d

Cleared Apr 24, 1997

Microbiology · 48d