The following data is part of a premarket notification filed by Dako Diagnostics Ltd. with the FDA for Imagearainfluenza Virus Group (types 1,2 And 3) Test And Imagen Parainfluenza Virus Test Types 1,2 And 3.
| Device ID | K981226 |
| 510k Number | K981226 |
| Device Name: | IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 |
| Classification | Antisera, Neutralization, Parainfluenza Virus 1-4 |
| Applicant | DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire, GB Cb7 4et |
| Contact | Ron Newstead |
| Correspondent | Ron Newstead DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire, GB Cb7 4et |
| Product Code | GQP |
| CFR Regulation Number | 866.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-24 |
| Decision Date | 1998-09-28 |
| Summary: | summary |