The following data is part of a premarket notification filed by Light Diagnostics with the FDA for Anti-nuclear Antibody(ana) Test Kit W/mouse Liver.
| Device ID | K944191 |
| 510k Number | K944191 |
| Device Name: | ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Applicant | LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Contact | Andras Peter |
| Correspondent | Andras Peter LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Product Code | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-29 |
| Decision Date | 1995-03-06 |