Company ยท US
Dade Microscan, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2005. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 26 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 10 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 2 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 1 |
| LRH | Instrument For Auto Reader Of Overnight Microorganism Identification System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 14, 2005 | K043589 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM Dade Microscan, Inc. | JWY |
| Oct 23, 2002 | K023202 | MICROSCAN SYNERGIES PLUS Dade Microscan, Inc. | JWY |
| Jun 20, 2002 | K021184 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN Dade Microscan, Inc. | LTT |
| Jun 17, 2002 | K021181 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN Dade Microscan, Inc. | JWY |
| Jun 11, 2002 | K021018 | MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL Dade Microscan, Inc. | JWY |
| Jun 6, 2002 | K021188 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME Dade Microscan, Inc. | JWY |
| Jun 6, 2002 | K021169 | MICROSTREP PLUS PANEL, AZITHROMYCIN Dade Microscan, Inc. | JWY |
| Jun 6, 2002 | K021111 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME Dade Microscan, Inc. | LTT |
| Jun 6, 2002 | K021110 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE Dade Microscan, Inc. | JWY |
| Jun 6, 2002 | K021078 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN Dade Microscan, Inc. | LTT |
| Jun 3, 2002 | K020938 | MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM Dade Microscan, Inc. | JWY |
| May 17, 2002 | K020939 | MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE Dade Microscan, Inc. | LTT |
| May 6, 2002 | K020937 | MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID Dade Microscan, Inc. | JWY |
| May 6, 2002 | K020627 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN Dade Microscan, Inc. | LTT |
| Apr 30, 2002 | K020691 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR Dade Microscan, Inc. | JWY |
| Apr 30, 2002 | K020686 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE Dade Microscan, Inc. | JWY |
| Apr 26, 2002 | K020626 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN Dade Microscan, Inc. | LTT |
| Apr 26, 2002 | K020556 | MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN Dade Microscan, Inc. | JWY |
| Apr 17, 2002 | K020506 | MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML) Dade Microscan, Inc. | LON |
| Mar 22, 2002 | K020037 | DRIED GRAM NEGATIVE MIC/COMBO PANELS Dade Microscan, Inc. | JWY |
| Mar 6, 2002 | K020511 | MICROSCAN SYNERGIES PLUS Dade Microscan, Inc. | LON |
| Dec 12, 2001 | K013423 | MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS Dade Microscan, Inc. | JWY |
| Jul 27, 2001 | K010159 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS Dade Microscan, Inc. | LTT |
| Jan 9, 2001 | K003619 | DRIED GRAM-POSITIVE MIC/COMBO PANELS Dade Microscan, Inc. | LTT |
| Feb 18, 2000 | K983943 | MICROSTREP PLUS PANEL, LEVOFLOXACIN Dade Microscan, Inc. | JWY |
| Jan 14, 2000 | K993679 | MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN Dade Microscan, Inc. | JWY |
| Jan 14, 2000 | K983953 | MICROSTREP PLUS PANEL, VANCOMYCIN Dade Microscan, Inc. | JWY |
| Dec 9, 1999 | K983746 | MICROSTREP PLUS PANEL Dade Microscan, Inc. | JWY |
| Dec 2, 1999 | K993102 | DRIED GRAM-POSITIVE MIC/COMBO PANELS Dade Microscan, Inc. | LTT |
| Jun 17, 1999 | K983922 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS Dade Microscan, Inc. | JWY |
| May 10, 1999 | K983408 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS Dade Microscan, Inc. | JWY |
| Apr 27, 1999 | K983711 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS Dade Microscan, Inc. | JWY |
| Nov 18, 1998 | K981199 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN Dade Microscan, Inc. | LRG |
| Oct 10, 1997 | K972799 | DRIED GRAM-POSITIVE MIC/COMBO PANELS Dade Microscan, Inc. | LTT |
| Sep 8, 1997 | K972688 | MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN Dade Microscan, Inc. | JWY |
| Aug 1, 1997 | K972180 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS Dade Microscan, Inc. | JWY |
| May 30, 1997 | K971376 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS Dade Microscan, Inc. | JWY |
| Dec 18, 1996 | K963641 | STREPTOCOCCUS MIC PANEL Dade Microscan, Inc. | JWY |
| May 30, 1996 | K961042 | MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL Dade Microscan, Inc. | LRH |
| Feb 23, 1996 | K955910 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS Dade Microscan, Inc. | JWY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||