Dade Microscan, Inc.
West Sacramento, CA, US
Dade Microscan, Inc. appears in FDA device records in West Sacramento, CA. FDA records list 40 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 40
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 40 510(k) clearances for Dade Microscan, Inc. between 1996 and 2005. The busiest year on record is 2002, with 20. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 3 |
| 1997 | 4 |
| 1998 | 1 |
| 1999 | 5 |
| 2000 | 3 |
| 2001 | 3 |
| 2002 | 20 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K043589 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM | JWY | Substantially Equivalent | |
| K023202 | MICROSCAN SYNERGIES PLUS | JWY | Substantially Equivalent | |
| K021184 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN | LTT | Substantially Equivalent | |
| K021181 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN | JWY | Substantially Equivalent | |
| K021018 | MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL | JWY | Substantially Equivalent | |
| K021188 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME | JWY | Substantially Equivalent | |
| K021169 | MICROSTREP PLUS PANEL, AZITHROMYCIN | JWY | Substantially Equivalent | |
| K021111 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME | LTT | Substantially Equivalent | |
| K021110 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE | JWY | Substantially Equivalent | |
| K021078 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN | LTT | Substantially Equivalent | |
| K020938 | MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM | JWY | Substantially Equivalent | |
| K020939 | MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE | LTT | Substantially Equivalent | |
| K020937 | MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID | JWY | Substantially Equivalent | |
| K020627 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN | LTT | Substantially Equivalent | |
| K020691 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR | JWY | Substantially Equivalent | |
| K020686 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE | JWY | Substantially Equivalent | |
| K020626 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN | LTT | Substantially Equivalent | |
| K020556 | MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN | JWY | Substantially Equivalent | |
| K020506 | MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML) | LON | Substantially Equivalent | |
| K020037 | DRIED GRAM NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K020511 | MICROSCAN SYNERGIES PLUS | LON | Substantially Equivalent | |
| K013423 | MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K010159 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | LTT | Substantially Equivalent | |
| K003619 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | LTT | Substantially Equivalent | |
| K983943 | MICROSTREP PLUS PANEL, LEVOFLOXACIN | JWY | Substantially Equivalent | |
| K993679 | MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN | JWY | Substantially Equivalent | |
| K983953 | MICROSTREP PLUS PANEL, VANCOMYCIN | JWY | Substantially Equivalent | |
| K983746 | MICROSTREP PLUS PANEL | JWY | Substantially Equivalent | |
| K993102 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | LTT | Substantially Equivalent | |
| K983922 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K983408 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K983711 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K981199 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN | LRG | Substantially Equivalent | |
| K972799 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | LTT | Substantially Equivalent | |
| K972688 | MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN | JWY | Substantially Equivalent | |
| K972180 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K971376 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K963641 | STREPTOCOCCUS MIC PANEL | JWY | Substantially Equivalent | |
| K961042 | MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL | LRH | Substantially Equivalent | |
| K955910 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- LRHInstrument For Auto Reader Of Overnight Microorganism Identification System
- JWYManual Antimicrobial Susceptibility Test Systems
- LTTPanels, Test, Susceptibility, Antimicrobial
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain