Imagearainfluenza Virus Group (Types 1,2 and 3) Test and Imagen Parainfluenza Virus Test Types 1,2 and 3
FDA 510(k) K981226 · Dako Diagnostics , Ltd.
510(k) numberK981226
Submission
- Device name
- Imagearainfluenza Virus Group (Types 1,2 and 3) Test and Imagen Parainfluenza Virus Test Types 1,2 and 3
- Applicant
- Dako Diagnostics , Ltd.
Cambridgeshire, GB - Received
- March 24, 1998
- Decision date
- September 28, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GQP – Antisera, Neutralization, Parainfluenza Virus 1-4
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3400
- Specialty
- Microbiology
Other 510(k)s with product code GQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933575 | Virastat(R) Fitc-Label Anti-Parainflu 1,2&3 Mono AntGQP · Traditional | Symex Corp. | 11/28/1994SE |
More from Symex Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K973954 | Imagen Respiratory ScreenGNW · Traditional | 12/22/1997SE |
| 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 Imagearainfluenza Virus Group (Types 1,2 and 3) Test and Imagen Parainfluenza Virus Test Types 1,2 and 3 cleared by the FDA?
Imagearainfluenza Virus Group (Types 1,2 and 3) Test and Imagen Parainfluenza Virus Test Types 1,2 and 3 (K981226) received a 510(k) decision of Substantially Equivalent on September 28, 1998, 188 days after the submission was received.
What is the product code of K981226?
The FDA product code is GQP – Antisera, Neutralization, Parainfluenza Virus 1-4, a Class I (low risk) device regulated under 21 CFR 866.3400.