COULTER COUNTER MODEL M5— 510(k) K853429

Name: FDA 510(k) clearance K853429
Creator: U.S. Food and Drug Administration
Published: 1985-10-10

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K853429 for COULTER COUNTER MODEL M5, Substantially Equivalent on 1985-10-10. Applicant: Coulter Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1985-08-15
Decision date: 1985-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

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