The following data is part of a premarket notification filed by Light Diagnostics with the FDA for Cytomegalovirus Indirect Immunofluorescence Assay.
| Device ID | K935809 |
| 510k Number | K935809 |
| Device Name: | CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY |
| Classification | Antigen, Cf (including Cf Control), Cytomegalovirus |
| Applicant | LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Contact | Dale Dembro |
| Correspondent | Dale Dembro LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Product Code | GQH |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-02 |
| Decision Date | 1994-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053252676024 | K935809 | 000 |
| 04061841047445 | K935809 | 000 |
| 04053252737183 | K935809 | 000 |
| 04053252731730 | K935809 | 000 |
| 04053252671074 | K935809 | 000 |
| 04053252589768 | K935809 | 000 |