XYLENE— 510(k) K812847

Substantially Equivalent

Richard-Allan Medical Ind., Inc.

FDA 510(k) clearance K812847 for XYLENE, Substantially Equivalent on 1981-10-29. Applicant: Richard-Allan Medical Ind., Inc.. Device class: 1.

Clearance details

Applicant: Richard-Allan Medical Ind., Inc.
Product code: Code KEM
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1981-10-09
Decision date: 1981-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KEM

K881282 — XYLENE1988-04-05
K874461 — HEMO-SOL1987-12-04
K861490 — PERMACLEAR SOLUTION CAT. NO. 49501986-05-06
K855109 — CLEARENE, CLEARING AGENT1986-01-07
K853694 — XYLENE SUBSTITUTE1985-10-22

More clearances from Richard-Allan Medical Ind., Inc.

K931879 — REFLEX HTR1994-03-24
K924200 — REFLEX(R) ESC1994-02-22
K926297 — REFLEX ESI1993-10-15
K924761 — STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD1993-04-20
K900566 — RICHARD-ALLAN VESSEL LOOPS1990-05-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.