CD8 CYTOSPHERES KIT— 510(k) K923951

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K923951 for CD8 CYTOSPHERES KIT, Substantially Equivalent on 1994-04-25. Applicant: Coulter Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code MAM
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1992-08-06
Decision date: 1994-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

More clearances from Coulter Electronics, Inc.

K930119 — COULTER RETIC-C CELL CONTROL1993-04-05
K921279 — CD4 CYTOSPHERES KIT1992-12-29
K923530 — COULTER MULTI-Q-PREP1992-10-14
K922181 — COULTER MH0091992-08-17
K922704 — COULTER MAXM W/ AUTOLOADER1992-07-27

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