FDA Product Code
FDA Product Code HYI — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1850
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K871286 | GRAM IODINE | Remel Co. | 1987-04-08 | Traditional | PDF ↗ |
| K842733 | GRAM IODINE | E K Ind., Inc. | 1984-08-10 | Traditional | PDF ↗ |
| K821977 | GRAMSTAIN SET | Granite Diagnostics, Inc. | 1982-07-22 | Traditional | PDF ↗ |
| K811722 | PARA-PAK | Meridian Diagnostics, Inc. | 1981-07-15 | Traditional | PDF ↗ |
| K791711 | IMPROVED GRAM STAIN REAGENTS | Carr-Scarborough Microbiologicals, Inc. | 1979-10-17 | Traditional | PDF ↗ |
| K781584 | GRAM STAIN KIT | Bioscientific | 1978-10-10 | Traditional | PDF ↗ |
Product code HYI · Class I · Hematology. Data: openFDA.