The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Cellmatics Rsv Detection System.
| Device ID | K862321 |
| 510k Number | K862321 |
| Device Name: | CELLMATICS RSV DETECTION SYSTEM |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Applicant | DIFCO LABORATORIES, INC. 1180 ELLSWORTH RD. Ann Arbor, MI 48104 |
| Contact | Walter S Fisher |
| Correspondent | Walter S Fisher DIFCO LABORATORIES, INC. 1180 ELLSWORTH RD. Ann Arbor, MI 48104 |
| Product Code | LKT |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-18 |
| Decision Date | 1986-08-21 |