The following data is part of a premarket notification filed by Immuno Concepts, N.a., Ltd with the FDA for Auto I.d. Jo-1, Scl-70 & Pcna Positive Control Serum.
| Device ID | K030775 |
| 510k Number | K030775 |
| Device Name: | AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM |
| Classification | Antinuclear Antibody, Antigen, Control |
| Applicant | IMMUNO CONCEPTS, N.A., LTD 2280 SPRINGLAKE RD. SUITE 106 Dallas, TX 75234 |
| Contact | Eric S Hoy |
| Correspondent | Eric S Hoy IMMUNO CONCEPTS, N.A., LTD 2280 SPRINGLAKE RD. SUITE 106 Dallas, TX 75234 |
| Product Code | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-11 |
| Decision Date | 2003-05-12 |