FDA 510(k) Applications Submitted by DADE MICROSCAN, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020037 |
01/04/2002 |
DRIED GRAM NEGATIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
| K010159 |
01/17/2001 |
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
| K020556 |
02/20/2002 |
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN |
DADE MICROSCAN, INC. |
| K020626 |
02/26/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN |
DADE MICROSCAN, INC. |
| K020627 |
02/26/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN |
DADE MICROSCAN, INC. |
| K020686 |
03/04/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE |
DADE MICROSCAN, INC. |
| K020691 |
03/04/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR |
DADE MICROSCAN, INC. |
| K020937 |
03/22/2002 |
MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID |
DADE MICROSCAN, INC. |
| K020938 |
03/22/2002 |
MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM |
DADE MICROSCAN, INC. |
| K020939 |
03/22/2002 |
MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE |
DADE MICROSCAN, INC. |
| K021078 |
04/03/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN |
DADE MICROSCAN, INC. |
| K021110 |
04/05/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE |
DADE MICROSCAN, INC. |
| K021111 |
04/05/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME |
DADE MICROSCAN, INC. |
| K021169 |
04/11/2002 |
MICROSTREP PLUS PANEL, AZITHROMYCIN |
DADE MICROSCAN, INC. |
| K021184 |
04/15/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN |
DADE MICROSCAN, INC. |
| K021188 |
04/15/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME |
DADE MICROSCAN, INC. |
| K021181 |
04/15/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN |
DADE MICROSCAN, INC. |
| K023202 |
09/25/2002 |
MICROSCAN SYNERGIES PLUS |
DADE MICROSCAN, INC. |
| K013423 |
10/02/2001 |
MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
| K983711 |
10/21/1998 |
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
| K983922 |
11/04/1998 |
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
| K003619 |
11/22/2000 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
| K043589 |
12/28/2004 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM |
DADE MICROSCAN, INC. |
| K021018 |
03/29/2002 |
MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL |
DADE MICROSCAN, INC. |
| K020511 |
02/15/2002 |
MICROSCAN SYNERGIES PLUS |
DADE MICROSCAN, INC. |
| K020506 |
02/15/2002 |
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML) |
DADE MICROSCAN, INC. |
| K972180 |
06/10/1997 |
DRIED GRAM-NEGATIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
| K961042 |
03/14/1996 |
MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL |
DADE MICROSCAN, INC. |
| K981199 |
04/02/1998 |
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN |
DADE MICROSCAN, INC. |
| K971376 |
04/14/1997 |
DRIED GRAM-NEGATIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
| K972688 |
07/07/1997 |
MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN |
DADE MICROSCAN, INC. |
| K972799 |
07/28/1997 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
| K963641 |
09/12/1996 |
STREPTOCOCCUS MIC PANEL |
DADE MICROSCAN, INC. |
| K983408 |
09/28/1998 |
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
| K983746 |
10/23/1998 |
MICROSTREP PLUS PANEL |
DADE MICROSCAN, INC. |
| K983943 |
11/05/1998 |
MICROSTREP PLUS PANEL, LEVOFLOXACIN |
DADE MICROSCAN, INC. |
| K983953 |
11/05/1998 |
MICROSTREP PLUS PANEL, VANCOMYCIN |
DADE MICROSCAN, INC. |
| K955910 |
12/29/1995 |
DRIED GRAM-NEGATIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
| K993102 |
09/16/1999 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
| K993679 |
11/01/1999 |
MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN |
DADE MICROSCAN, INC. |
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