LYSING REAGENT— 510(k) K832182

Substantially Equivalent

Omega Medical Diagnostics

FDA 510(k) clearance K832182 for LYSING REAGENT, Substantially Equivalent on 1983-08-12. Applicant: Omega Medical Diagnostics. Device class: 1.

Clearance details

Applicant: Omega Medical Diagnostics
Product code: Code GGK
Device class: Class 1
Regulation: 21 CFR 864.8540
Advisory panel: Hematology
Date received: 1983-07-07
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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 Omega Medical Diagnostics

K831619 — SODIUM HYPOCHLORITE 7%1983-07-28
K831620 — SODIUM HYPOCHLORITE 3%1983-07-28
K831617 — DILUENT1983-06-16
K831618 — HEMOGLOBIN REAGENT1983-06-16

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