The following data is part of a premarket notification filed by Immuno-products Industries with the FDA for Ana/lite-hep-2 Test System.
| Device ID | K852231 |
| 510k Number | K852231 |
| Device Name: | ANA/LITE-HEP-2 TEST SYSTEM |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | IMMUNO-PRODUCTS INDUSTRIES P.O. BOX 286 So. Bound Brook, NJ 08880 |
| Contact | Howard Rubinstein |
| Correspondent | Howard Rubinstein IMMUNO-PRODUCTS INDUSTRIES P.O. BOX 286 So. Bound Brook, NJ 08880 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-22 |
| Decision Date | 1985-07-10 |