MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
FDA 510(k) clearance K092300 · decided 2009-08-28
Clearance details
- K-number
- K092300
- Device name
- MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
- Applicant
- Diagnostic Hybrids, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-29
- Decision date
- 2009-08-28
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- GNW
- Device class
- 1
- Regulation number
- 866.3330
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Athens, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT (K092882) | Diagnostic Hybrids, Inc. | 2009-10-21 |
| D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT (K081746) | Diagnostic Hybrids, Inc. | 2008-12-23 |
| D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (K061101) | Diagnostic Hybrids, Inc. | 2006-11-20 |
| DFA RESPIRATORY VIRUS SCREENING & ID KIT (K022713) | Diagnostic Hybrids, Inc. | 2002-12-18 |
| BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT (K003204) | Intracel Corp. | 2000-11-07 |
| LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B (K974302) | Light Diagnostics | 1998-04-08 |
| IMAGEN RESPIRATORY SCREEN (K973954) | Dako Diagnostics , Ltd. | 1997-12-22 |
| IMAGEN RESPIRATORY SCREEN (K962037) | Dako Diagnostics , Ltd. | 1996-12-26 |
| INFLUENZA A ANTIGEN TEST (K942172) | Neogenex | 1994-07-06 |
| INFLUENZA B ANITGEN TEST (K942174) | Neogenex | 1994-06-30 |
| INFLUENZA MAB TEST/INFLUENZA A TEST (K913351) | Gull Laboratories, Inc. | 1991-12-17 |
| INFLUENZA MAB TEST/INFLUENZA B TEST (K913214) | Gull Laboratories, Inc. | 1991-12-13 |
Recalls involving this device
No recalls on record reference this clearance.