The following data is part of a premarket notification filed by Light Diagnostics with the FDA for Light Diagnostics Simulfluor Hsv 1/2 Immunofluorecence Assay.
| Device ID | K991880 |
| 510k Number | K991880 |
| Device Name: | LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Contact | Cindy Penny |
| Correspondent | Cindy Penny LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-02 |
| Decision Date | 1999-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053252589942 | K991880 | 000 |
| 04053252625213 | K991880 | 000 |
| 04053252515101 | K991880 | 000 |