The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Igg Anti-ndna Fluorescent Test System; Model # 3040g.
| Device ID | K013432 |
| 510k Number | K013432 |
| Device Name: | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G |
| Classification | Anti-dna Indirect Immunofluorescent Solid Phase |
| Applicant | IMMUNO CONCEPTS, INC. 9779 BUSINESS PARK DR. SUITE D Sacramento, CA 95827 |
| Contact | Eric S Hoy |
| Correspondent | Eric S Hoy IMMUNO CONCEPTS, INC. 9779 BUSINESS PARK DR. SUITE D Sacramento, CA 95827 |
| Product Code | KTL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2001-11-29 |
| Summary: | summary |