GRAM-NEGATIVE QUICKFISH BC
FDA 510(k) clearance K123418 · decided 2013-07-21
Clearance details
- K-number
- K123418
- Device name
- GRAM-NEGATIVE QUICKFISH BC
- Applicant
- Advandx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-06
- Decision date
- 2013-07-21
- Days to decision
- 257 days
- Clearance type
- Traditional
- Product code
- JSS
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| hemoFISH Masterpanel (K150031) | Miacom Diagnostics GmbH | 2015-10-01 |
| GNR TRAFFIC LIGHT PNA FISH (K101558) | Advandx, Inc. | 2010-12-16 |
| E.COLI/P. AERUGINOSA PNA FISH (K092236) | Advandx, Inc. | 2009-12-16 |
| EK/P. AERUGINOSA PNA FISH (K092393) | Advandx, Inc. | 2009-09-01 |
| E. COLI PNA FISH (K082068) | Advandx, Inc. | 2009-06-25 |
| EK/P. AERUGINOSA PNA FISH (K081433) | Advandx, Inc. | 2009-03-26 |
| E.COLI/P. AERUGINOSA PNA FISH (K081309) | Advandx, Inc. | 2008-12-19 |
| ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (K926002) | Alamar Biosciences Laboratory, Inc. | 1993-09-23 |
| API 20E/UNISCEPT 20E (K924814) | Analytical Products, Inc. | 1993-03-11 |
| CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM (K926017) | Becton Dickinson Microbiology Systems | 1993-03-11 |
| CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM (K926018) | Becton Dickinson Microbiology Systems | 1993-03-11 |
| ROCHE ENTEROTUBE II (K922588) | Roche Diagnostic Systems, Inc. | 1992-09-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enteroba recall (Z-0619-2014) | AdvanDx, Inc. | 2014-01-02 |