FDA Product Code
FDA Product Code KTO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5530
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K894416 | RAICHEM(TM) SPIA(TM) IGG REAGENTS | Reagents Applications, Inc. | 1989-08-01 | Traditional | PDF ↗ |
| K854483 | KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT | Kallestad Laboratories, Inc. | 1985-12-11 | Traditional | PDF ↗ |
Product code KTO · Class I · Immunology. Data: openFDA.