COULTER MULTI-Q-PREP— 510(k) K923530

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K923530 for COULTER MULTI-Q-PREP, Substantially Equivalent on 1992-10-14. Applicant: Coulter Electronics, Inc.. Device class: 1.

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code GKH
Device class: Class 1
Regulation: 21 CFR 864.5240
Advisory panel: Hematology
Date received: 1992-07-16
Decision date: 1992-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKH

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K935953 — COULTER MULTI Q PREP1994-03-11

More clearances from Coulter Electronics, Inc.

K923951 — CD8 CYTOSPHERES KIT1994-04-25
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K921279 — CD4 CYTOSPHERES KIT1992-12-29
K922181 — COULTER MH0091992-08-17
K922704 — COULTER MAXM W/ AUTOLOADER1992-07-27

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