The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Hep-2000 Fluorescent Ana-ro Test System.
| Device ID | K944096 |
| 510k Number | K944096 |
| Device Name: | HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | IMMUNO CONCEPTS, INC. 8712 ROYAL LN. Irving, TX 75063 |
| Contact | Eric S Hoy |
| Correspondent | Eric S Hoy IMMUNO CONCEPTS, INC. 8712 ROYAL LN. Irving, TX 75063 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-22 |
| Decision Date | 1994-11-21 |