CDL LYSING REAGENT— 510(k) K822500

Name: FDA 510(k) clearance K822500
Creator: U.S. Food and Drug Administration
Published: 1982-09-17

Substantially Equivalent

Connecticut Diagnostics, Ltd.

FDA 510(k) clearance K822500 for CDL LYSING REAGENT, Substantially Equivalent on 1982-09-17. Applicant: Connecticut Diagnostics, Ltd.. Device class: 1.

Clearance details

Applicant: Connecticut Diagnostics, Ltd.
Product code: Code GGK
Device class: Class 1
Regulation: 21 CFR 864.8540
Advisory panel: Hematology
Date received: 1982-08-18
Decision date: 1982-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGK

view all

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 Connecticut Diagnostics, Ltd.

view all

K905617 — VISI-STAPH1991-03-29
K822501 — CDL ISOTONIC DILUENT1982-09-17
K822504 — CDL AUTO-LYSING REAGENT1982-09-17
K811222 — INORGANIC PHOSPHORUS REAGENTS1981-05-21
K801897 — GLUCOSE DIAGNOSTIC REAGENT1980-10-10

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