Product code KEM
- Device name
- Agent, Clearing
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.4010
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881282 | XYLENE | Anatech, Ltd. | 1988-04-05 |
| K874461 | HEMO-SOL | Chem Pharm, Inc. | 1987-12-04 |
| K861490 | PERMACLEAR SOLUTION CAT. NO. 4950 | Helena Laboratories | 1986-05-06 |
| K855109 | CLEARENE, CLEARING AGENT | Surgipath Medical Industries, Inc. | 1986-01-07 |
| K853694 | XYLENE SUBSTITUTE | Lerner Laboratories, Inc. | 1985-10-22 |
| K854083 | XYLENE SUBSTITUTE MONTANT | Lerner Laboratories, Inc. | 1985-10-22 |
| K842861 | PRO-PAR CLEARANT | Anatech, Ltd. | 1984-08-21 |
| K842721 | LIMONENE | E K Ind., Inc. | 1984-08-03 |
| K832011 | AMERI CLEAR | Stephens Scientific | 1983-08-12 |
| K832451 | CLEAR-RITE 3 | Richard-Allan Medical Ind., Inc. | 1983-08-12 |
| K830627 | CLARIFIER-RICHARD-ALLAN | Richard-Allan Medical Ind., Inc. | 1983-03-24 |
| K822784 | HEMO-DE | Pmp Industries | 1982-11-05 |
| K812846 | CLEAR-RITE II | Richard-Allan Medical Ind., Inc. | 1981-10-29 |
| K812847 | XYLENE | Richard-Allan Medical Ind., Inc. | 1981-10-29 |
| K811798 | CLEAR-RITE | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 50885380043268 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-01-06 |
| 10885380043260 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2026-01-06 |
| 20613647028630 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 00613647028438 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 00613647028506 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 00613647028513 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 00613647028636 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 20613647028517 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 20613647028500 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 20613647028432 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2025-04-30 |
| 00673693101608 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-23 |
| 00673693087032 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-23 |
| 00673693088923 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-23 |
| 00673693101561 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-23 |
| 00673693101592 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-23 |
| 00673693476126 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-23 |
| 00673693228374 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-23 |
| 00673693236102 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-23 |
| 00673693236133 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-23 |
| 00673693236140 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-23 |
| 00673693086974 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-07-23 |
| 00810047421016 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047421009 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420996 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420989 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420583 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420309 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00613647023754 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| M52550050 | Clear Aid | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52549500 | PermaClear Clearing Solution | HELENA LABORATORIES CORPORATION | 2017-03-17 |