FDA Product Code
FDA Product Code KEM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Pathology
- 21 CFR Citation
- 864.4010
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K881282 | XYLENE | Anatech, Ltd. | 1988-04-05 | Traditional | PDF ↗ |
| K874461 | HEMO-SOL | Chem Pharm, Inc. | 1987-12-04 | Traditional | PDF ↗ |
| K861490 | PERMACLEAR SOLUTION CAT. NO. 4950 | Helena Laboratories | 1986-05-06 | Traditional | PDF ↗ |
| K855109 | CLEARENE, CLEARING AGENT | Surgipath Medical Industries, Inc. | 1986-01-07 | Traditional | PDF ↗ |
| K853694 | XYLENE SUBSTITUTE | Lerner Laboratories, Inc. | 1985-10-22 | Traditional | PDF ↗ |
| K854083 | XYLENE SUBSTITUTE MONTANT | Lerner Laboratories, Inc. | 1985-10-22 | Traditional | PDF ↗ |
| K842861 | PRO-PAR CLEARANT | Anatech, Ltd. | 1984-08-21 | Traditional | PDF ↗ |
| K842721 | LIMONENE | E K Ind., Inc. | 1984-08-03 | Traditional | PDF ↗ |
| K832011 | AMERI CLEAR | Stephens Scientific | 1983-08-12 | Traditional | PDF ↗ |
| K832451 | CLEAR-RITE 3 | Richard-Allan Medical Ind., Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K830627 | CLARIFIER-RICHARD-ALLAN | Richard-Allan Medical Ind., Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K822784 | HEMO-DE | Pmp Industries | 1982-11-05 | Traditional | PDF ↗ |
| K812846 | CLEAR-RITE II | Richard-Allan Medical Ind., Inc. | 1981-10-29 | Traditional | PDF ↗ |
| K812847 | XYLENE | Richard-Allan Medical Ind., Inc. | 1981-10-29 | Traditional | PDF ↗ |
| K811798 | CLEAR-RITE | Richard-Allan Medical Ind., Inc. | 1981-07-28 | Traditional | PDF ↗ |
Product code KEM · Class I · Pathology. Data: openFDA.