CELL-DYN RAPID-LYSE AND HEMOGLOBLIN— 510(k) K881242

Name: FDA 510(k) clearance K881242
Creator: U.S. Food and Drug Administration
Published: 1988-04-21

Substantially Equivalent

Abbott Diagnostics

FDA 510(k) clearance K881242 for CELL-DYN RAPID-LYSE AND HEMOGLOBLIN, Substantially Equivalent on 1988-04-21. Applicant: Abbott Diagnostics. Device class: 2.

Clearance details

Applicant: Abbott Diagnostics
Product code: Code GJZ
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1988-03-16
Decision date: 1988-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GJZ

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K883683 — HEMOGLOBIN1988-10-06

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K890491 — CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER1989-04-18
K881130 — CELL-DYN ISOTONIC DILUENT1988-03-31

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