KEM
15 FDA 510(k) clearances · Product code
21 daysmedian time to decision
50 days90th percentile
15clearances measured
FDA profile
- Official device name
- Agent, Clearing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.4010
- Medical specialty
- Pathology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| XYLENE (K881282) | Anatech, Ltd. | 1988-04-05 |
| HEMO-SOL (K874461) | Chem Pharm, Inc. | 1987-12-04 |
| PERMACLEAR SOLUTION CAT. NO. 4950 (K861490) | Helena Laboratories | 1986-05-06 |
| CLEARENE, CLEARING AGENT (K855109) | Surgipath Medical Industries, Inc. | 1986-01-07 |
| XYLENE SUBSTITUTE (K853694) | Lerner Laboratories, Inc. | 1985-10-22 |
| XYLENE SUBSTITUTE MONTANT (K854083) | Lerner Laboratories, Inc. | 1985-10-22 |
| PRO-PAR CLEARANT (K842861) | Anatech, Ltd. | 1984-08-21 |
| LIMONENE (K842721) | E K Ind., Inc. | 1984-08-03 |
| CLEAR-RITE 3 (K832451) | Richard-Allan Medical Ind., Inc. | 1983-08-12 |
| AMERI CLEAR (K832011) | Stephens Scientific | 1983-08-12 |
| CLARIFIER-RICHARD-ALLAN (K830627) | Richard-Allan Medical Ind., Inc. | 1983-03-24 |
| HEMO-DE (K822784) | Pmp Industries | 1982-11-05 |
| XYLENE (K812847) | Richard-Allan Medical Ind., Inc. | 1981-10-29 |
| CLEAR-RITE II (K812846) | Richard-Allan Medical Ind., Inc. | 1981-10-29 |
| CLEAR-RITE (K811798) | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
Track KEM automatically
Every clearance here is in the API, with alerts when new ones post.