The following data is part of a premarket notification filed by Intl. Diagnostic Technology with the FDA for Antinuclear Antibody Immunological Sys.
| Device ID | K834140 |
| 510k Number | K834140 |
| Device Name: | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS |
| Classification | Anti-dna Indirect Immunofluorescent Solid Phase |
| Applicant | INTL. DIAGNOSTIC TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-30 |
| Decision Date | 1984-01-20 |