XYLENE SUBSTITUTE— 510(k) K853694

Substantially Equivalent

Lerner Laboratories, Inc.

FDA 510(k) clearance K853694 for XYLENE SUBSTITUTE, 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: 1985-09-04
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

K881282 — XYLENE1988-04-05
K874461 — HEMO-SOL1987-12-04
K861490 — PERMACLEAR SOLUTION CAT. NO. 49501986-05-06
K855109 — CLEARENE, CLEARING AGENT1986-01-07
K854083 — XYLENE SUBSTITUTE MONTANT1985-10-22

More clearances from Lerner Laboratories, Inc.

K821443 — FORMICAL1982-06-02
K761000 — PAP-TRAY I (CATALOG #C600-1)1976-12-06
K761001 — PAP-TRAY II (CATALOG #C600-2)1976-12-06

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