Agent, Clearing
FDA product code KEM · Class I (low risk) · 21 CFR 864.4010 · Pathology
15510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881282 | XyleneKEM · Traditional | Anatech, Ltd. | 04/05/1988SE |
| K874461 | Hemo-SolKEM · Traditional | Chem Pharm, Inc. | 12/04/1987SE |
| K861490 | Permaclear Solution Cat. No. 4950KEM · Traditional | Helena Laboratories | 05/06/1986SE |
| K855109 | Clearene, Clearing AgentKEM · Traditional | Surgipath Medical Industries, Inc. | 01/07/1986SE |
| K854083 | Xylene Substitute MontantKEM · Traditional | Lerner Laboratories, Inc. | 10/22/1985SE |
| K853694 | Xylene SubstituteKEM · Traditional | Lerner Laboratories, Inc. | 10/22/1985SE |
| K842861 | Pro-Par ClearantKEM · Traditional | Anatech, Ltd. | 08/21/1984SE |
| K842721 | LimoneneKEM · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K832451 | Clear-Rite 3KEM · Traditional | Richard-Allan Medical Ind., Inc. | 08/12/1983SE |
| K832011 | Ameri ClearKEM · Traditional | Stephens Scientific | 08/12/1983SE |
| K830627 | Clarifier-Richard-AllanKEM · Traditional | Richard-Allan Medical Ind., Inc. | 03/24/1983SE |
| K822784 | Hemo-DeKEM · Traditional | Pmp Industries | 11/05/1982SE |
| K812847 | XyleneKEM · Traditional | Richard-Allan Medical Ind., Inc. | 10/29/1981SE |
| K812846 | Clear-Rite IIKEM · Traditional | Richard-Allan Medical Ind., Inc. | 10/29/1981SE |
| K811798 | Clear-RiteKEM · Traditional | Richard-Allan Medical Ind., Inc. | 07/28/1981SE |