The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Bartels Respiratory Syncytial Virus Enzyme Immuno.
| Device ID | K912838 |
| 510k Number | K912838 |
| Device Name: | BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Applicant | BAXTER DIAGNOSTICS, INC. BARTELS DIAGNOSTICS DIVISION P.O. BOX 3093 Bellevue, WA 98009 |
| Contact | Scott Dennis |
| Correspondent | Scott Dennis BAXTER DIAGNOSTICS, INC. BARTELS DIAGNOSTICS DIVISION 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 | 1991-06-26 |
| Decision Date | 1991-09-27 |