The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Respiratory Syncytial Virus Direct Fluorescent Ant.
| Device ID | K852185 |
| 510k Number | K852185 |
| Device Name: | RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Applicant | BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. P.O. BOX 3093 Bellevue, WA 98009 |
| Contact | Howard Taylor |
| Correspondent | Howard Taylor BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. P.O. BOX 3093 Bellevue, WA 98009 |
| Product Code | LKT |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-20 |
| Decision Date | 1985-08-19 |