KEM — Agent, Clearing Class I
FDA product code KEM covers "Agent, Clearing", a Class I medical device regulated under 21 CFR 864.4010. Submissions are reviewed by the Pathology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KEM
- Device Class
- Class I
- Regulation Number
- 864.4010
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K881282 | anatech | XYLENE | April 5, 1988 |
| K874461 | chem pharm | HEMO-SOL | December 4, 1987 |
| K861490 | helena laboratories | PERMACLEAR SOLUTION CAT. NO. 4950 | May 6, 1986 |
| K855109 | surgipath medical industries | CLEARENE, CLEARING AGENT | January 7, 1986 |
| K853694 | lerner laboratories | XYLENE SUBSTITUTE | October 22, 1985 |
| K854083 | lerner laboratories | XYLENE SUBSTITUTE MONTANT | October 22, 1985 |
| K842861 | anatech | PRO-PAR CLEARANT | August 21, 1984 |
| K842721 | e k ind | LIMONENE | August 3, 1984 |
| K832011 | stephens scientific | AMERI CLEAR | August 12, 1983 |
| K832451 | richard-allan medical ind | CLEAR-RITE 3 | August 12, 1983 |
| K830627 | richard-allan medical ind | CLARIFIER-RICHARD-ALLAN | March 24, 1983 |
| K822784 | pmp industries | HEMO-DE | November 5, 1982 |
| K812847 | richard-allan medical ind | XYLENE | October 29, 1981 |
| K812846 | richard-allan medical ind | CLEAR-RITE II | October 29, 1981 |
| K811798 | richard-allan medical ind | CLEAR-RITE | July 28, 1981 |