FDA Product Code
FDA Product Code CZN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K891683 | TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER | Helena Laboratories | 1989-04-12 | Traditional | PDF ↗ |
| K855011 | QUANTIMETRIC PLUS C3 REAGENT KIT | Kallestad Laboratories, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K841815 | OPTIMATE IGA TEST | Miles Laboratories, Inc. | 1984-06-01 | Traditional | PDF ↗ |
| K832262 | FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS | Gelco Diagnostics, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K832257 | GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC | Gelco Diagnostics, Inc. | 1983-10-28 | Traditional | PDF ↗ |
| K831909 | RABBIT ANTISERUM TO HUMAN IGA | Dako Corp. | 1983-07-18 | Traditional | PDF ↗ |
| K831607 | FIAX IGA TEST KIT | Intl. Diagnostic Technology | 1983-06-22 | Traditional | PDF ↗ |
Product code CZN · Class II · Immunology. Data: openFDA.