LYSE-TEC— 510(k) K840289

Substantially Equivalent

Medilab Corp.

FDA 510(k) clearance K840289 for LYSE-TEC, Substantially Equivalent on 1984-03-05. Applicant: Medilab Corp.. Device class: 1.

Clearance details

Applicant: Medilab Corp.
Product code: Code GGK
Device class: Class 1
Regulation: 21 CFR 864.8540
Advisory panel: Hematology
Date received: 1984-01-24
Decision date: 1984-03-05
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 Medilab Corp.

K841862 — IMMU-TEC1984-06-13
K841863 — MONO-TEC1984-06-13
K840290 — MCS TOTAL PROTEIN REAGENT1984-03-30
K840291 — MCS ALBUMIN REAGENT1984-03-30
K832918 — PREGNA-TEC1983-11-03

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