Product code KEM— Pathology
XYLENE
- Classification name
- Agent, Clearing
- Device class
- Class 1
- Regulation
- 21 CFR 864.4010
- Advisory panel
- Pathology
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code KEM
FDA has cleared devices under product code KEM between 1981 and 1988, filed by 9 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
- 1982
- 1981
Top applicants under product code KEM
Recent clearances under product code KEM
- K881282 — XYLENE
- K874461 — HEMO-SOL
- K861490 — PERMACLEAR SOLUTION CAT. NO. 4950
- K855109 — CLEARENE, CLEARING AGENT
- K853694 — XYLENE SUBSTITUTE
- K854083 — XYLENE SUBSTITUTE MONTANT
- K842861 — PRO-PAR CLEARANT
- K842721 — LIMONENE
- K832011 — AMERI CLEAR
- K832451 — CLEAR-RITE 3
- K830627 — CLARIFIER-RICHARD-ALLAN
- K822784 — HEMO-DE
- K812846 — CLEAR-RITE II
- K812847 — XYLENE
- K811798 — CLEAR-RITE
Data sourced from openFDA. This site is unofficial and independent of the FDA.