The following data is part of a premarket notification filed by Light Diagnostics with the FDA for Light Diagnostics Simulfluor Hsv/vzv Immunoflourescence Assay, Model 3295.
| Device ID | K990141 |
| 510k Number | K990141 |
| Device Name: | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 |
| Classification | Antigen, Cf, (including Cf Control), Varicella-zoster |
| 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 | GQW |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-19 |
| Decision Date | 1999-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053252371745 | K990141 | 000 |
| 04053252370960 | K990141 | 000 |