FDA Product Code
FDA Product Code ICF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1850
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K864531 | TISSUE GRAM STAIN | Sigma Diagnostics, Inc. | 1986-12-22 | Traditional | PDF ↗ |
| K842537 | VON WILLEBRAND FACTOR ANTIGEN SCREEN | American Dade | 1984-10-01 | Traditional | PDF ↗ |
| K842730 | GENTIAN VIOLET | E K Ind., Inc. | 1984-08-03 | Traditional | PDF ↗ |
| K821503 | IRIS URINE STAIN | Intl. Remote Imaging Systems | 1982-06-03 | Traditional | PDF ↗ |
| K792495 | VOLU-SOL URINARY SEDIMENT STAIN | Volu Sol Medical Industries | 1979-12-18 | Traditional | PDF ↗ |
Product code ICF · Class I · Hematology. Data: openFDA.