LASER-LYSE— 510(k) K850097

Substantially Equivalent

Hematology Marketing Assoc.

FDA 510(k) clearance K850097 for LASER-LYSE, Substantially Equivalent on 1985-03-29. Applicant: Hematology Marketing Assoc.. Device class: 1.

Clearance details

Applicant: Hematology Marketing Assoc.
Product code: Code GGK
Device class: Class 1
Regulation: 21 CFR 864.8540
Advisory panel: Hematology
Date received: 1985-01-11
Decision date: 1985-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, 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 Hematology Marketing Assoc.

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