Custodiol HTK Solution— 510(k) K192408

Name: FDA 510(k) clearance K192408
Creator: U.S. Food and Drug Administration
Published: 2020-04-24

Substantially Equivalent

Dr. Franz Kohler Chemie GmbH

FDA 510(k) clearance K192408 for Custodiol HTK Solution, Substantially Equivalent on 2020-04-24. Applicant: Dr. Franz Kohler Chemie GmbH. Device class: 2.

Clearance details

Applicant: Dr. Franz Kohler Chemie GmbH
Product code: Code KDL
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2019-09-04
Decision date: 2020-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bensheim, DE

Download summary PDF View on FDA.gov ↗

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More clearances from Dr. Franz Kohler Chemie GmbH

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K043461 — CUSTODIOL2005-02-28
K032794 — CUSTODIOL2004-04-05
K020924 — CUSTODIOL HTK SOLUTION2003-01-06
K992209 — CUSTODIOL1999-12-10

Recalls naming K192408

K-number listed on FDA's recall record

Z-3300-2024 — Custodiol HTK Solution, 500ml bottle. 10 per carton.Class II·Ongoing·Dr Franz Koehler Chemie Gmbh·20240109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192408.

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