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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05032384503070 | K973954 | 000 |