The following data is part of a premarket notification filed by Genetic Systems Corp. with the FDA for Genetic Systems Rsv Immunofluorescence Test Kit.
| Device ID | K870176 |
| 510k Number | K870176 |
| Device Name: | GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Applicant | GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
| Contact | Bogdan Dziurzynski |
| Correspondent | Bogdan Dziurzynski GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
| Product Code | LKT |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-15 |
| Decision Date | 1987-07-16 |