FDA 510(k) Applications Submitted by MAUREEN MENDE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020142 |
01/16/2002 |
MICROSCAN SYNERGIES PLUS |
DADE BEHRING, INC. |
| K020168 |
01/17/2002 |
MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) |
DADE BEHRING, INC. |
| K020173 |
01/17/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML) |
DADE BEHRING, INC. |
| K020182 |
01/18/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML) |
DADE BEHRING, INC. |
| K020185 |
01/18/2002 |
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML) |
DADE BEHRING, INC. |
| K020209 |
01/22/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML) |
DADE BEHRING, INC. |
| K020246 |
01/24/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML) |
DADE BEHRING, INC. |
| K020248 |
01/24/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML) |
DADE BEHRING, INC. |
| K020249 |
01/24/2002 |
MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML) |
DADE BEHRING, INC. |
| K020319 |
01/30/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML) |
DADE BEHRING, INC. |
| K020328 |
01/31/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML) |
DADE BEHRING, INC. |
| K020397 |
02/06/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML) |
DADE BEHRING, INC. |
| K020398 |
02/06/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) |
DADE BEHRING, INC. |
| K020410 |
02/07/2002 |
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML) |
DADE BEHRING, INC. |
| K020413 |
02/07/2002 |
MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML) |
DADE BEHRING, INC. |
| K020506 |
02/15/2002 |
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML) |
DADE MICROSCAN, INC. |
| K020511 |
02/15/2002 |
MICROSCAN SYNERGIES PLUS |
DADE MICROSCAN, INC. |
| K061536 |
06/02/2006 |
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
| K061687 |
06/15/2006 |
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
| K061872 |
07/03/2006 |
MICROSCAN MICROSTREP PLUS PANEL |
DADE BEHRING, INC. |
| DEN160032 |
07/11/2016 |
Accelerate Pheno system, Accelerate Phenotest BC Kit |
ACCELERATE DIAGNOTICS |
| K062276 |
08/07/2006 |
MICROSCAN MICROSTREP PLUS PANEL |
DADE BEHRING, INC. |
| K062293 |
08/07/2006 |
MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML) |
DADE BEHRING, INC. |
| K062375 |
08/15/2006 |
MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) |
DADE BEHRING, INC. |
| K062777 |
09/18/2006 |
MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN |
DADE BEHRING, INC. |
| K063064 |
10/06/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) |
DADE BEHRING, INC. |
| K063065 |
10/06/2006 |
MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) |
DADE BEHRING, INC. |
| K063101 |
10/10/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML |
DADE BEHRING, INC. |
| K103112 |
10/21/2010 |
AFFYMETRIX GENE PROFILING REAGENTS |
Affymetrix, Inc. |
| K080995 |
04/07/2008 |
MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM |
Affymetrix, Inc. |
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