Remel, Inc. - FDA 510(k) Cleared Devices
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Remel, Inc. Microbiology ✕
17 devices
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
PAR-ONE
Microbiology
88d
Cleared
Apr 24, 1997
PYR SWAB
Microbiology
48d
Cleared
Apr 17, 1997
GRAM SWAB
Microbiology
41d
Cleared
Apr 02, 1997
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK
Microbiology
26d
Cleared
Apr 02, 1997
REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
Microbiology
26d
Cleared
Apr 02, 1997
INDOLE SWAB
Microbiology
26d
Cleared
Sep 19, 1994
REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG
Microbiology
280d