COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II— 510(k) K883836

Name: FDA 510(k) clearance K883836
Creator: U.S. Food and Drug Administration
Published: 1988-11-30

Substantially Equivalent

Coulter Immunology

FDA 510(k) clearance K883836 for COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II, Substantially Equivalent on 1988-11-30. Applicant: Coulter Immunology. Device class: 1.

Clearance details

Applicant: Coulter Immunology
Product code: Code GGK
Device class: Class 1
Regulation: 21 CFR 864.8540
Advisory panel: Hematology
Date received: 1988-09-12
Decision date: 1988-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

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K863114 — PIASTRINIT1986-11-06
K863503 — HEMOLYSE1986-10-03

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K910473 — CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC1991-10-31
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