FDA Product Code
FDA Product Code DHN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5100
510(k) Clearances — 110 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K780178 | TEST SYS. FOR NDNA ANTIBODY DETERM. | Zeus Scientific, Inc. | 1978-02-13 | Traditional | PDF ↗ |
| K780161 | IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER | Zeus Scientific, Inc. | 1978-02-07 | Traditional | PDF ↗ |
| K772219 | FIAX TEST FOR ANTI-RUBELLA ANTIBODY | Idt, A Division of Whittaker M.A. Bioproducts | 1978-01-20 | Traditional | PDF ↗ |
| K771376 | IFA ANTI-NDNA | Electro-Nucleonics Laboratories, Inc. | 1977-10-18 | Traditional | PDF ↗ |
| K771064 | ANA TEST | Gull Laboratories, Inc. | 1977-06-24 | Traditional | PDF ↗ |
| K770057 | NDNA IMMUNOPATH FLUORO-KIT | Clinical Sciences, Inc. | 1977-04-05 | Traditional | PDF ↗ |
| K760681 | INDIRECT FLUORESCENT (IFA-ANA) | Wampole Laboratories | 1976-10-21 | Traditional | PDF ↗ |
| K760206 | TEST, DETECTION, ANTINUCLEAR ANTIBODIES | Intl. Diagnostic Technology | 1976-08-03 | Traditional | PDF ↗ |
| K760209 | ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP | Zeus Scientific, Inc. | 1976-07-26 | Traditional | PDF ↗ |
| K760153 | TEST, (IVDP) ANTINUCLEAR ANTIBODY | Zeus Scientific, Inc. | 1976-07-20 | Traditional | PDF ↗ |
Product code DHN · Class II · Immunology. Data: openFDA.