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Remel, Inc.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K162620 Remel Spectra ESBLJSO2017-05-01 View
510(k) K131804 REMEL XPECT FLU A&BGNX2013-07-12 View
510(k) K092407 REMEL SPECTRA MRSAJSO2010-10-08 View
510(k) K072827 RPMI 1640 AGAR W/MOPS AND 2% GLUCOSEMJE2007-11-26 View
510(k) K041951 XPECT CLOSTRIDIUM DIFFICILE TOXIN A/BLLH2004-11-15 View
510(k) K033479 PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAYLLH2004-02-26 View
510(k) K031942 XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020MHI2003-11-18 View
510(k) K031965 XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020MHJ2003-11-14 View
510(k) K031834 XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAYMHI2003-11-10 View
510(k) K031565 XPECT INFLUENZA A/BPSZ2003-07-17 View
510(k) K981391 PAR-ONELIO1998-07-14 View
510(k) K970832 PYR SWABJTO1997-04-24 View
510(k) K970834 GRAM SWABJTO1997-04-17 View
510(k) K970830 REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISKJTN1997-04-02 View
510(k) K970833 INDOLE SWABJTO1997-04-02 View
510(k) K970831 REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISKJTN1997-04-02 View
510(k) K935975 REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCGJTN1994-09-19 View
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