COULTER CELLPREP— 510(k) K021150

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K021150 for COULTER CELLPREP, Substantially Equivalent on 2002-06-11. Applicant: Beckman Coulter, Inc.. Device class: 1.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code GKH
Device class: Class 1
Regulation: 21 CFR 864.5240
Advisory panel: Hematology
Date received: 2002-04-10
Decision date: 2002-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKH

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K040077 — IMMUNICON CELLTRACKS AUTOPREP SYSTEM2004-03-12
K022512 — CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 95182002-09-30
K935953 — COULTER MULTI Q PREP1994-03-11
K923530 — COULTER MULTI-Q-PREP1992-10-14

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