FLUID, RHEMOX W LYSING— 510(k) K790029

Substantially Equivalent

Sysmex Corp.

FDA 510(k) clearance K790029 for FLUID, RHEMOX W LYSING, Substantially Equivalent on 1979-02-26. Applicant: Sysmex Corp.. Device class: 1.

Clearance details

Applicant: Sysmex Corp.
Product code: Code GGK
Device class: Class 1
Regulation: 21 CFR 864.8540
Advisory panel: Hematology
Date received: 1979-01-03
Decision date: 1979-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGK

K883836 — COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II1988-11-30
K883991 — KVM HEMOGLOBIN LYSING REAGENT1988-10-12
K874054 — FISHER DIAGNOSTICS HEMATALL III LAS REAGENT1987-10-20
K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.1987-09-09
K863114 — PIASTRINIT1986-11-06

More clearances from Sysmex Corp.

K012372 — SYSMEX UF-502001-09-28
K992875 — SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER1999-11-09
K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-35001998-11-03
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.