HC PLUS— 510(k) K833563

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K833563 for HC PLUS, Substantially Equivalent on 1984-01-03. Applicant: Coulter Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1983-10-12
Decision date: 1984-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Coulter Electronics, Inc.

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K923530 — COULTER MULTI-Q-PREP1992-10-14
K922181 — COULTER MH0091992-08-17

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