Imagen Respiratory Screen
FDA 510(k) K973954 · Dako Diagnostics , Ltd.
510(k) numberK973954
Submission
- Device name
- Imagen Respiratory Screen
- Applicant
- Dako Diagnostics , Ltd.
Cambridgeshire, GB - Received
- October 9, 1997
- Decision date
- December 22, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K092300 | Modification to D3 Ultra Dfa Respiratory Virus Screening & Id KitGNW · Special | Diagnostic Hybrids, Inc. | 08/28/2009SE |
| 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 |
| 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 |
|---|---|---|
| K981226 | Imagearainfluenza Virus Group (Types 1,2 and 3) Test and Imagen Parainfluenza Virus Test…GQP · Traditional | 09/28/1998SE |
| K962037 | Imagen Respiratory ScreenGNW · Traditional | 12/26/1996SE |
| K940564 | Ideia(Tm) Chlamydia Blocking Reagents, ModificationLJC · Traditional | 01/11/1996SE |
| K943557 | ImagenGQS · Traditional | 01/09/1995SE |
| K932384 | Ideia(Tm) RotavirusLIQ · Traditional | 12/27/1993SE |
Questions and answers
When was Imagen Respiratory Screen cleared by the FDA?
Imagen Respiratory Screen (K973954) received a 510(k) decision of Substantially Equivalent on December 22, 1997, 74 days after the submission was received.
What is the product code of K973954?
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.