XYLENE
FDA 510(k) clearance K812847 · decided 1981-10-29
Clearance details
- K-number
- K812847
- Device name
- XYLENE
- Applicant
- Richard-Allan Medical Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-10-09
- Decision date
- 1981-10-29
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- KEM
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.