The following data is part of a premarket notification filed by Dako Diagnostics Ltd. with the FDA for Imagen Respiratory Screen.
| Device ID | K973954 |
| 510k Number | K973954 |
| Device Name: | IMAGEN RESPIRATORY SCREEN |
| Classification | Antisera, Cf, Influenza Virus A, B, C |
| Applicant | DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire, GB Cb7 4et |
| Contact | Elisabeth Silver |
| Correspondent | Elisabeth Silver DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire, GB Cb7 4et |
| Product Code | GNW |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-09 |
| Decision Date | 1997-12-22 |
| Summary: | summary |