DILUENT, CELLENT BLOOD— 510(k) K790028

Substantially Equivalent

Sysmex Corp.

FDA 510(k) clearance K790028 for DILUENT, CELLENT BLOOD, Substantially Equivalent on 1979-02-15. Applicant: Sysmex Corp.. Device class: 1.

Clearance details

Applicant: Sysmex Corp.
Product code: Code GIF
Device class: Class 1
Regulation: 21 CFR 864.8200
Advisory panel: Hematology
Date received: 1979-01-03
Decision date: 1979-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K881130 — CELL-DYN ISOTONIC DILUENT1988-03-31

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K981761 — SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER1998-08-14
K971736 — SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER1997-08-26

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