FDA 510(k) Applications Submitted by REMEL, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K072827 |
10/03/2007 |
RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE |
REMEL, INC. |
| K131804 |
06/19/2013 |
REMEL XPECT FLU A&B |
REMEL, INC. |
| K162620 |
09/20/2016 |
Remel Spectra ESBL |
REMEL, INC. |
| K970830 |
03/07/1997 |
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK |
REMEL, INC. |
| K970831 |
03/07/1997 |
REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK |
REMEL, INC. |
| K970832 |
03/07/1997 |
PYR SWAB |
REMEL, INC. |
| K970833 |
03/07/1997 |
INDOLE SWAB |
REMEL, INC. |
| K970834 |
03/07/1997 |
GRAM SWAB |
REMEL, INC. |
| K981391 |
04/17/1998 |
PAR-ONE |
REMEL, INC. |
| K092407 |
08/06/2009 |
REMEL SPECTRA MRSA |
REMEL, INC. |
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