The following data is part of a premarket notification filed by Light Diagnostics with the FDA for Varicella-zoster Virus Direct Immunofluorescence Assay.
| Device ID | K951799 |
| 510k Number | K951799 |
| Device Name: | VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY |
| Classification | Antiserum, Cf, Varicella-zoster |
| Applicant | LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Contact | Dale Dembrow |
| Correspondent | Dale Dembrow LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Product Code | GQX |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-19 |
| Decision Date | 1996-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053252732638 | K951799 | 000 |
| 04053252792861 | K951799 | 000 |
| 04053252285547 | K951799 | 000 |