Modification to D3 Ultra Dfa Respiratory Virus Screening & Id Kit
FDA 510(k) K092300 · Diagnostic Hybrids, Inc.
510(k) numberK092300
Submission
- Device name
- Modification to D3 Ultra Dfa Respiratory Virus Screening & Id Kit
- Applicant
- Diagnostic Hybrids, Inc.
Athens, OH, US - Received
- July 29, 2009
- Decision date
- August 28, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GNW – Antisera, Cf, Influenza Virus A, B, C
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3330
- Specialty
- Microbiology
Other 510(k)s with product code GNW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092882 | D3 Fastpoint L-Dfa Influenza A/Influenza B Virus Identification KitGNW · Traditional | Diagnostic Hybrids, Inc. | 10/21/2009SE |
| K081746 | D3 Duet Dfa Influenza A/Respiratory Virus Screening KitGNW · Traditional | Diagnostic Hybrids, Inc. | 12/23/2008SE |
| K061101 | D3 Ultra Dfa Respiratory Virus Screening & Id KitGNW · Traditional | Diagnostic Hybrids, Inc. | 11/20/2006SE |
| K022713 | Dfa Respiratory Virus Screening & Id KitGNW · Traditional | Diagnostic Hybrids, Inc. | 12/18/2002SE |
| K003204 | Bartels Viral Respiratory Screening and Identification KitGNW · Special | Intracel Corp. | 11/07/2000SE |
| K974302 | Light Diagnostics Simulfluor Flu A/Flu BGNW · Traditional | Light Diagnostics | 04/08/1998SE |
| K973954 | Imagen Respiratory ScreenGNW · Traditional | Dako Diagnostics , Ltd. | 12/22/1997SE |
| K962037 | Imagen Respiratory ScreenGNW · Traditional | Dako Diagnostics , Ltd. | 12/26/1996SE |
| K942172 | Influenza a Antigen TestGNW · Traditional | Neogenex | 07/06/1994SE |
| K942174 | Influenza B Anitgen TestGNW · Traditional | Neogenex | 06/30/1994SE |
More from Neogenex
| 510(k) | Device | Decision |
|---|---|---|
| K092229 | Thyretain TM Tsi Reporter BioassayJZO · Traditional | 05/18/2010SE |
| K093415 | D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification KitGQS · Traditional | 12/23/2009SE |
| K093233 | D3 Fastpoint L-Dfa Rsv/Mvp Identification KitOMG · Traditional | 12/04/2009SE |
| K092882 | D3 Fastpoint L-Dfa Influenza A/Influenza B Virus Identification KitGNW · Traditional | 10/21/2009SE |
| K091171 | D3 Ultra Duet Dfa Respiratory Virus Identification KitOMG · Traditional | 09/11/2009SE |
| K091753 | Elvis HSV Id and D3 Typing Test SystemGQL · Traditional | 08/28/2009SE |
| K083391 | Thyroid Stimulating Immunoglobulin Reporter AssayJZO · Traditional | 05/21/2009SE |
| K090073 | D3 Dfa Metapneumovirus Identification KitOMG · Traditional | 03/06/2009SE |
| K081928 | D3 Duet Dfa Rsv/Respiratory Virus Screening KitLKT · Traditional | 12/23/2008SE |
| K081746 | D3 Duet Dfa Influenza A/Respiratory Virus Screening KitGNW · Traditional | 12/23/2008SE |
Questions and answers
When was Modification to D3 Ultra Dfa Respiratory Virus Screening & Id Kit cleared by the FDA?
Modification to D3 Ultra Dfa Respiratory Virus Screening & Id Kit (K092300) received a 510(k) decision of Substantially Equivalent on August 28, 2009, 30 days after the submission was received.
What is the product code of K092300?
The FDA product code is GNW – Antisera, Cf, Influenza Virus A, B, C, a Class I (low risk) device regulated under 21 CFR 866.3330.