The following data is part of a premarket notification filed by Boots-celltech Diagnostics, Inc. with the FDA for Imagen Respiratory Syncytial Virus Test.
Device ID | K854081 |
510k Number | K854081 |
Device Name: | IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST |
Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
Applicant | BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
Contact | John G Simpson |
Correspondent | John G Simpson BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
Product Code | GQG |
CFR Regulation Number | 866.3480 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-10-07 |
Decision Date | 1986-01-03 |