K990141 is an FDA 510(k) clearance for the LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295. This device is classified as a Antigen, Cf, (including Cf Control), Varicella-zoster (Class II - Special Controls, product code GQW).
Submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on October 19, 1999, 273 days after receiving the submission on January 19, 1999.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3900.
| 510(k) Number | K990141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1999 |
| Decision Date | October 19, 1999 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GQW — Antigen, Cf, (including Cf Control), Varicella-zoster |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3900 |