FDA Product Code
FDA Product Code KSI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.9550
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K820368 | LECTIN-A | American Dade | 1982-04-14 | Traditional | PDF ↗ |
| K813413 | LECTIN H | American Dade | 1982-03-04 | Traditional | PDF ↗ |
| K792582 | POLY-LEC SYSTEM | Gamma Biologicals, Inc. | 1980-01-16 | Traditional | PDF ↗ |
| K792583 | GAMMA ARACHIS HYPOGEA LECTIN | Gamma Biologicals, Inc. | 1980-01-16 | Traditional | PDF ↗ |
Product code KSI · Class II · Hematology. Data: openFDA.