XYLENE SUBSTITUTE MONTANT— 510(k) K854083

Name: FDA 510(k) clearance K854083
Creator: U.S. Food and Drug Administration
Published: 1985-10-22

Substantially Equivalent

Lerner Laboratories, Inc.

FDA 510(k) clearance K854083 for XYLENE SUBSTITUTE MONTANT, Substantially Equivalent on 1985-10-22. Applicant: Lerner Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Lerner Laboratories, Inc.
Product code: Code KEM
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1985-10-07
Decision date: 1985-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Haven, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KEM

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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

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